ResearchPad - 1707 https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Study protocol for a multicentre longitudinal mixed methods study to explore the Outcomes of ChildrEn and fAmilies in the first year after paediatric Intensive Care: the OCEANIC study]]> https://www.researchpad.co/article/elastic_article_12542 Annually in the UK, 20 000 children become very ill or injured and need specialist care within a paediatric intensive care unit (PICU). Most children survive. However, some children and their families may experience problems after they have left the PICU including physical, functional and/or emotional problems. It is unknown which children and families experience such problems, when these occur or what causes them. The aim of this mixed-method longitudinal cohort study is to understand the physical, functional, emotional and social impact of children surviving PICU (aged: 1 month–17 years), their parents and siblings, during the first year after a PICU admission.Methods and analysisA quantitative study involving 300 child survivors of PICU; 300 parents; and 150–300 siblings will collect data (using self-completion questionnaires) at baseline, PICU discharge, 1, 3, 6 and 12 months post-PICU discharge. Questionnaires will comprise validated and reliable instruments. Demographic data, PICU admission and treatment data, health-related quality of life, functional status, strengths and difficulties behaviour and post-traumatic stress symptoms will be collected from the child. Parent and sibling data will be collected on the impact of paediatric health conditions on the family’s functioning capabilities, levels of anxiety and social impact of the child’s PICU admission. Data will be analysed using descriptive and inferential statistics. Concurrently, an embedded qualitative study involving semistructured interviews with 24 enrolled families at 3 months and 9 months post-PICU discharge will be undertaken. Framework analysis will be used to analyse the qualitative data.Ethics and disseminationThe study has received ethical approval from the National Health Services Research Ethics Committee (Ref: 19/WM/0290) and full governance clearance. This will be the first UK study to comprehensively investigate physical, functional, emotional and social consequences of PICU survival in the first-year postdischarge.Clinical Trials Registration Number: ISRCTN28072812 [Pre-results] ]]> <![CDATA[Managing new-onset atrial fibrillation in critically ill patients: a systematic narrative review]]> https://www.researchpad.co/article/elastic_article_9123 The aim of this review is to summarise the latest evidence on efficacy and safety of treatments for new-onset atrial fibrillation (NOAF) in critical illness.ParticipantsCritically ill adult patients who developed NOAF during admission.Primary and secondary outcomesPrimary outcomes were efficacy in achieving rate or rhythm control, as defined in each study. Secondary outcomes included mortality, stroke, bleeding and adverse events.MethodsWe searched MEDLINE, EMBASE and Web of Knowledge on 11 March 2019 to identify randomised controlled trials (RCTs) and observational studies reporting treatment efficacy for NOAF in critically ill patients. Data were extracted, and quality assessment was performed using the Cochrane Risk of Bias Tool, and an adapted Newcastle-Ottawa Scale.ResultsOf 1406 studies identified, 16 remained after full-text screening including two RCTs. Study quality was generally low due to a lack of randomisation, absence of blinding and small cohorts. Amiodarone was the most commonly studied agent (10 studies), followed by beta-blockers (8), calcium channel blockers (6) and magnesium (3). Rates of successful rhythm control using amiodarone varied from 30.0% to 95.2%, beta-blockers from 31.8% to 92.3%, calcium channel blockers from 30.0% to 87.1% and magnesium from 55.2% to 77.8%. Adverse effects of treatment were rarely reported (five studies).ConclusionThe reported efficacy of beta-blockers, calcium channel blockers, magnesium and amiodarone for achieving rhythm control was highly varied. As there is currently significant variation in how NOAF is managed in critically ill patients, we recommend future research focuses on comparing the efficacy and safety of amiodarone, beta-blockers and magnesium. Further research is needed to inform the decision surrounding anticoagulant use in this patient group. ]]> <![CDATA[Using a machine learning approach to predict mortality in critically ill influenza patients: a cross-sectional retrospective multicentre study in Taiwan]]> https://www.researchpad.co/article/N6388ab39-5c97-4641-916e-2125a9dede2c

Objectives

Current mortality prediction models used in the intensive care unit (ICU) have a limited role for specific diseases such as influenza, and we aimed to establish an explainable machine learning (ML) model for predicting mortality in critically ill influenza patients using a real-world severe influenza data set.

Study design

A cross-sectional retrospective multicentre study in Taiwan

Setting

Eight medical centres in Taiwan.

Participants

A total of 336 patients requiring ICU-admission for virology-proven influenza at eight hospitals during an influenza epidemic between October 2015 and March 2016.

Primary and secondary outcome measures

We employed extreme gradient boosting (XGBoost) to establish the prediction model, compared the performance with logistic regression (LR) and random forest (RF), demonstrated the feature importance categorised by clinical domains, and used SHapley Additive exPlanations (SHAP) for visualised interpretation.

Results

The data set contained 76 features of the 336 patients with severe influenza. The severity was apparently high, as shown by the high Acute Physiology and Chronic Health Evaluation II score (22, 17 to 29) and pneumonia severity index score (118, 88 to 151). XGBoost model (area under the curve (AUC): 0.842; 95% CI 0.749 to 0.928) outperformed RF (AUC: 0.809; 95% CI 0.629 to 0.891) and LR (AUC: 0.701; 95% CI 0.573 to 0.825) for predicting 30-day mortality. To give clinicians an intuitive understanding of feature exploitation, we stratified features by the clinical domain. The cumulative feature importance in the fluid balance domain, ventilation domain, laboratory data domain, demographic and symptom domain, management domain and severity score domain was 0.253, 0.113, 0.177, 0.140, 0.152 and 0.165, respectively. We further used SHAP plots to illustrate associations between features and 30-day mortality in critically ill influenza patients.

Conclusions

We used a real-world data set and applied an ML approach, mainly XGBoost, to establish a practical and explainable mortality prediction model in critically ill influenza patients.

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<![CDATA[Is haemoglobin below 7.0 g/dL an optimal trigger for allogenic red blood cell transfusion in patients admitted to intensive care units? A meta-analysis and systematic review]]> https://www.researchpad.co/article/N8b890b98-2524-4045-a18f-5ab464786995

Objectives

We employed a comprehensive systematic review and meta-analysis to assess benefits and risks of a threshold of haemoglobin level below 7 g/dL versus liberal transfusion strategy among critically ill patients, and even patients with septic shock.

Design

Systematic review and meta-analysis.

Data sources

We performed systematical searches for relevant randomised controlled trials (RCTs) in the Cochrane Library, EMBASE and PubMed databases up to 1 September 2019.

Eligibility criteria

RCTs among adult intensive care unit (ICU) patients comparing 7 g/dL as restrictive strategy with liberal transfusion were incorporated.

Data extraction and synthesis

The clinical outcomes, including short-term mortality, length of hospital stay, length of ICU stay, myocardial infarction (MI) and ischaemic events, were screened and analysed after data collection. We applied odds ratios (ORs) to analyse dichotomous outcomes and standardised mean differences (SMDs) to analyse continuous outcomes with fixed or random effects models based on heterogeneity evaluation for each outcome.

Results

Eight RCTs with 3415 patients were included. Compared with a more liberal threshold, a red blood cell (RBC) transfusion threshold <7 g/dL haemoglobin showed no significant difference in short-term mortality (OR: 0.90, 95% CI: 0.67 to 1.21, p=0.48, I2=53%), length of hospital stay (SMD: −0.11, 95% CI: −0.30 to 0.07, p=0.24, I2=71%), length of ICU stay (SMD: −0.03, 95% CI: −0.14 to 0.08, p=0.54, I2=0%) or ischaemic events (OR: 0.80, 95% CI: 0.43 to 1.48, p=0.48, I2=51%). However, we found that the incidence of MI (OR: 0.54, 95% CI: 0.30 to 0.98, p=0.04, I2=0%) was lower in the group with the threshold <7 g/dL than that with the more liberal threshold.

Conclusions

An RBC transfusion threshold <7 g/dL haemoglobin is incapable of decreasing short-term mortality in ICU patients according to currently published evidences, while it might have potential role in reducing MI incidence.

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<![CDATA[Core competencies in neurocritical care training in China: consensus developed by a national Delphi consensus survey combined with nominal group technique]]> https://www.researchpad.co/article/N4c7dda3d-3920-49f6-bfde-41dd84fcadae

Objectives

To define the core competencies essential for specialist training in neurocritical care in China.

Design

Modified Delphi method and nominal group (NG) technique.

Setting

National.

Participants

A total of 1094 respondents from 33 provinces in China participated in the online survey. A NG of 11 members was organised by the Neuro-Critical Care Committee affiliated with the Chinese Association of Critical Care Physicians and the National Center for Healthcare Quality Management in Neurological Diseases.

Results

1094 respondents from 33 provinces in China participated in the online survey. A formal list containing 329 statements was generated for the rating by a NG. After five rounds of NG meetings and one round of comments and iterative review, 198 core competencies (54 on neurological diseases, 64 on general medical diseases, 42 on monitoring of practical procedures, 20 on professionalism and system management, five on ethical and legal aspects, three on the principles of research and certification and 10 on scoring systems) formed the final list.

Conclusion

By using consensus techniques, we have developed a list of core competencies for neurocritical care training, which may serve as a reference for future specialist training programmes in China.

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<![CDATA[Development and validation of a postoperative delirium prediction model for patients admitted to an intensive care unit in China: a prospective study]]> https://www.researchpad.co/article/N00c4718a-d2e7-49df-9fb0-7c29f9579da1

Objectives

We aimed to develop and validate a postoperative delirium (POD) prediction model for patients admitted to the intensive care unit (ICU).

Design

A prospective study was conducted.

Setting

The study was conducted in the surgical, cardiovascular surgical and trauma surgical ICUs of an affiliated hospital of a medical university in Heilongjiang Province, China.

Participants

This study included 400 patients (≥18 years old) admitted to the ICU after surgery.

Primary and secondary outcome measures

The primary outcome measure was POD assessment during ICU stay.

Results

The model was developed using 300 consecutive ICU patients and was validated using 100 patients from the same ICUs. The model was based on five risk factors: Physiological and Operative Severity Score for the enumeration of Mortality and morbidity; acid–base disturbance and history of coma, diabetes or hypertension. The model had an area under the receiver operating characteristics curve of 0.852 (95% CI 0.802 to 0.902), Youden index of 0.5789, sensitivity of 70.73% and specificity of 87.16%. The Hosmer-Lemeshow goodness of fit was 5.203 (p=0.736). At a cutoff value of 24.5%, the sensitivity and specificity were 71% and 69%, respectively.

Conclusions

The model, which used readily available data, exhibited high predictive value regarding risk of ICU-POD at admission. Use of this model may facilitate better implementation of preventive treatments and nursing measures.

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<![CDATA[Sedation AND Weaning In Children (SANDWICH): protocol for a cluster randomised stepped wedge trial]]> https://www.researchpad.co/article/Nd909315b-7f85-4833-81b0-ed018ca8a5a6

Introduction

Weaning from ventilation is a complex process involving several stages that include recognition of patient readiness to begin the weaning process, steps to reduce ventilation while optimising sedation in order not to induce distress and removing the endotracheal tube. Delay at any stage can prolong the duration of mechanical ventilation. We developed a multicomponent intervention targeted at helping clinicians to safely expedite this process and minimise the harms associated with unnecessary mechanical ventilation.

Methods and analysis

This is a 20-month cluster randomised stepped wedge clinical and cost-effectiveness trial with an internal pilot and a process evaluation. It is being conducted in 18 paediatric intensive care units in the UK to evaluate a protocol-based intervention for reducing the duration of invasive mechanical ventilation. Following an initial 8-week baseline data collection period in all sites, one site will be randomly chosen to transition to the intervention every 4 weeks and will start an 8-week training period after which it will continue the intervention for the remaining duration of the study. We aim to recruit approximately 10 000 patients. The primary analysis will compare data from before the training (control) with that from after the training (intervention) in each site. Full details of the analyses will be in the statistical analysis plan.

Ethics and dissemination

This protocol was reviewed and approved by NRES Committee East Midlands—Nottingham 1 Research Ethics Committee (reference: 17/EM/0301). All sites started patient recruitment on 5 February 2018 before randomisation in April 2018. Results will be disseminated in 2020. The results will be presented at national and international conferences and published in peer-reviewed medical journals.

Trial registration number

ISRCTN16998143.

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<![CDATA[Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency: a study protocol of a multicentre, placebo-controlled double-blind phase III RCT (the VITDALIZE study)]]> https://www.researchpad.co/article/Nb182c195-d0e6-495f-9764-aaa1e0c3a713

Introduction

Observational studies have demonstrated an association between vitamin D deficiency and increased risk of morbidity and mortality in critically ill patients. Cohort studies and pilot trials have suggested promising beneficial effects of vitamin D replacement in the critical ill, at least in patients with severe vitamin D deficiency. As vitamin D is a simple, low-cost and safe intervention, it has potential to improve survival in critically ill patients.

Methods and analysis

In this randomised, placebo-controlled, double-blind, multicentre, international trial, 2400 adult patients with severe vitamin D deficiency (25-hydroxyvitamin D≤12 ng/mL) will be randomised in a 1:1 ratio by www.randomizer.at to receive a loading dose of 540 000 IU cholecalciferol within 72 hours after intensive care unit (ICU) admission, followed by 4000 IU daily for 90 days or placebo. Hypercalcaemia may occur as a side effect, but is monitored by regular checks of the calcium level. The primary outcome is all-cause mortality at 28 days after randomisation. Secondary outcomes are: ICU, hospital, 90-day and 1-year mortality; hospital and ICU length of stay, change in organ dysfunction on day 5 as measured by Sequential Organ Function Assessment (SOFA) score, number of organ failures; hospital and ICU readmission until day 90; discharge destination, self-reported infections requiring antibiotics until day 90 and health-related quality of life. Recruitment status is ongoing.

Ethics and dissemination

National ethical approval was obtained by the Ethics Committee of the University of Graz for Austria, Erasme University Brussels (Belgium) and University Hospital Frankfurt (Germany), and will further be gained according to individual national processes. On completion, results will be published in a peer-reviewed scientific journal. The study findings will be presented at national and international meetings with abstracts online.

Trial registration

NCT03188796, EudraCT-No: 2016-002460-13.

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<![CDATA[Vitamin C therapy for patients with sepsis or septic shock: a protocol for a systematic review and a network meta-analysis]]> https://www.researchpad.co/article/N8e7b6e4d-6fdb-4120-854f-e69ed0f183b7

Introduction

Vasoplegia is common and associated with a poor prognosis in patients with sepsis and septic shock. Vitamin C therapy in combination with vitamin B1 and glucocorticoid, as well as monotherapy in various doses, has been investigated as a treatment for the vasoplegic state in sepsis, through targeting the inflammatory cascade. However, the combination effect and the relative contribution of each drug have not been well evaluated. Furthermore, the best combination between the three agents is currently unknown. We are planning a systematic review (SR) with network meta-analysis (NMA) to compare the different treatments and identify the combination with the most favourable effect on survival.

Methods and analysis

We will include all randomised controlled trials comparing any intervention using intravenous vitamin C, vitamin B1 and/or glucocorticoid with another or with placebo in the treatment of sepsis. We are interested in comparing the following active interventions. Very high-dose vitamin C (≥12 g/day), high-dose vitamin C (≥6 g/day), vitamin C (<6 g/day); low-dose glucocorticoid (<400 mg/day of hydrocortisone (or equivalent)), vitamin B1 and combinations of the drugs above. The primary outcome will be all-cause mortality at the longest follow-up within 1 year but 90 days or longer postrandomisation. All relevant studies will be sought through database searches and trial registries. All reference selection and data extraction will be conducted by two independent reviewers. We will conduct a random-effects NMA to synthesise all evidence for each outcome and obtain a comprehensive ranking of all treatments. We will use the surface under the cumulative ranking curve and the mean ranks to rank the various interventions. To differentiate between the effect of combination therapies and the effect of a component, we will employ a component NMA.

Ethics and dissemination

This SR does not require ethical approval. We will publish findings from this systematic review in a peer-reviewed scientific journal and present these at scientific conferences.

PROSPERO registration number

CRD42018103860.

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<![CDATA[Identifying intensive care unit discharge planning tools: protocol for a scoping review]]> https://www.researchpad.co/article/5acb9c5e463d7e1582fcaf34

Background

Transitions of care between providers are vulnerable periods in healthcare delivery that expose patients to preventable errors and adverse events. Patient discharge from the intensive care unit (ICU) to a medical or surgical hospital ward is one of the most challenging and high risk transitions of care. Approximately 1 in 12 patients discharged will be readmitted to ICU or die before leaving the hospital. Many more patients are exposed to unnecessary healthcare, adverse events and/or are disappointed with the quality of their care. Our objective is to conduct a scoping review by systematically searching the literature to identify ICU discharge planning tools and their supporting evidence-base including barriers and facilitators to their use.

Methods and analysis

Systematic searching of the published health literature will be conducted to identify the existing ICU discharge planning tools and supporting evidence. Literature (research and non-research) reporting on the tools used to facilitate decision making and/or communication at ICU discharge with patients of any age will be included. Outcomes will include adverse events and provider and patient/family-reported outcomes. Two investigators will independently review the abstracts (screen 1) to identify those meeting the inclusion criteria and then independently assess the full text articles (screen 2) to determine if they meet the inclusion criteria. Data collection will include information on citations and identified tools. A quality assessment will be performed on original research studies. A descriptive summary will be developed for each tool.

Ethics and dissemination

Our scoping review will synthesise the literature for ICU discharge planning tools and identify the opportunities for knowledge to action and gaps in evidence where primary evidence is necessary. This will serve as the foundational element in a multistep research programme to standardise and improve the quality of care provided to patients during ICU discharge. Ethics approval is not required for this study.

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<![CDATA[First results about recovery of walking function in patients with intensive care unit-acquired muscle weakness from the General Weakness Syndrome Therapy (GymNAST) cohort study]]> https://www.researchpad.co/article/5af699bd463d7e59b1023af6

Objectives

To describe the time course of recovery of walking function and other activities of daily living in patients with intensive care unit (ICU)-acquired muscle weakness.

Design

This is a cohort study.

Participants

We included critically ill patients with ICU-acquired muscle weakness.

Setting

Post-acute ICU and rehabilitation units in Germany.

Measures

We measured walking function, muscle strength, activities in daily living, motor and cognitive function.

Results

We recruited 150 patients (30% female) who fulfilled our inclusion and exclusion criteria. The primary outcome recovery of walking function was achieved after a median of 28.5 days (IQR=45) after rehabilitation onset and after a median of 81.5 days (IQR=64) after onset of illness. Our final multivariate model for recovery of walking function included two clinical variables from baseline: the Functional Status Score ICU (adjusted HR=1.07 (95% CI 1.03 to 1.12) and the ability to reach forward in cm (adjusted HR=1.02 (95% CI 1.00 to 1.04). All secondary outcomes but not pain improved significantly in the first 8 weeks after study onset.

Conclusions

We found good recovery of walking function for most patients and described the recovery of walking function of people with ICU-acquired muscle weakness.

Trials registrations number

Sächsische Landesärztekammer EK-BR-32/13-1; DRKS00007181, German Register of Clinical Trials.

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<![CDATA[Trends of vital signs with gestational age in normal pregnancies: a systematic review protocol]]> https://www.researchpad.co/article/5af80aa8463d7e7ed0704f6f

Introduction

Vital signs (blood pressure, heart rate, temperature, oxygen saturation and respiratory rate) are thought to undergo changes during and immediately after pregnancy. However, these physiological changes are not taken into account in the normal ranges, which themselves are not evidence-based, used in routine and acute care monitoring. We aim to synthesise the existing evidence base for changes in vital signs during pregnancy, in order to derive new centile charts for each stage of pregnancy and the immediate postpartum period.

Methods and analysis

We will search the MEDLINE, EMBASE and CINAHL databases from their inception to April 2015 for vital signs from pregnant, intrapartum or postpartum women who were recruited as ‘healthy’. Assessment of bias will be conducted using a predefined set of independently agreed methodological criteria, which assigns an overall quality score to each study. We will record whether the vital sign measurements were made with measurement devices validated for use in pregnancy and in a standard posture. We will use regression methods to construct centile charts of vital signs across pregnancy and the immediate postpartum period for each vital sign. We will compare existing reference ranges to those derived from our centile charts.

Dissemination

The systematic review will be published in a peer-reviewed journal and disseminated electronically and in print.

PROSPERO reference

CRD42014009673.

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<![CDATA[Early intervention of patients at risk for acute respiratory failure and prolonged mechanical ventilation with a checklist aimed at the prevention of organ failure: protocol for a pragmatic stepped-wedged cluster trial of PROOFCheck]]> https://www.researchpad.co/article/5afefc40463d7e1ed32769b4

Introduction

Acute respiratory failure (ARF) often presents and progresses outside of the intensive care unit. However, recognition and treatment of acute critical illness is often delayed with inconsistent adherence to evidence-based care known to decrease the duration of mechanical ventilation (MV) and complications of critical illness. The goal of this trial is to determine whether the implementation of an electronic medical record-based early alert for progressive respiratory failure coupled with a checklist to promote early compliance to best practice in respiratory failure can improve the outcomes of patients at risk for prolonged respiratory failure and death.

Methods and analysis

A pragmatic stepped-wedged cluster clinical trial involving 6 hospitals is planned. The study will include adult hospitalised patients identified as high risk for MV >48 hours or death because they were mechanically ventilated outside of the operating room or they were identified as high risk for ARF on the Accurate Prediction of PROlonged VEntilation (APPROVE) score. Patients with advanced directives limiting intubation will be excluded. The intervention will consist of (1) automated identification and notification of clinician of high-risk patients by APPROVE or by invasive MV and (2) checklist of evidence-based practices in ARF (Prevention of Organ Failure Checklist—PROOFCheck). APPROVE and PROOFCheck will be developed in the pretrial period. Primary outcome is hospital mortality. Secondary outcomes include length of stay, ventilator and organ failure-free days and 6-month and 12-month mortality. Predefined subgroup analysis of patients with limitation of aggressive care after study entry is planned. Generalised estimating equations will be used to compare patients in the intervention phase with the control phase, adjusting for clustering within hospitals and time.

Ethics and dissemination

The study was approved by the institutional review boards. Results will be published in peer-reviewed journals and presented at international meetings.

Trial registration number

NCT02488174.

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<![CDATA[Comparison of Enteral versus Intravenous Potassium Supplementation in hypokalaemia in postcardiac surgery paediatric cardiac intensive care patients: prospective open label randomised control trial (EIPS)]]> https://www.researchpad.co/article/5ba6ea6b40307c4ae697c75f

Background

Hypokalaemia is frequently encountered in the daily clinical practices of a paediatric cardiac intensive care unit (PCICU). It is a strong independent predictor of mortality in patients with heart failure. Thus, prompt potassium replacement therapy holds pivotal importance in therapy for hypokalaemia. Although intravenous potassium replacement (IVPR) in hypokalaemia is the preferred route in most intensive care settings, it is associated with known safety risks and can lead to arrhythmias, cardiac arrest and death if inappropriately administered. Enteral potassium replacement (EPR), with its superior safety profile, may be a better alternative to IVPR.

Outcome

Primary outcome To compare the efficacy EPR and IVPR for treatment of hypokalaemia. Secondary outcome measures include a comparison of adverse effects (hyperkalaemia, diarrhoea, gastrointestinal bleeds, nausea and vomiting) after EPR and IVPR and a comparison of the number of dose/s required to achieve resolution of hypokalaemia for each episode of hypokalaemia.

Methods and analysis

The Enteral Versus Intravenous Potassium Supplementation trial is designed as a randomised, controlled, non-blinded trial with two arms. Intervention arms will be block randomised on alternate weeks for IVPR and EPR. Recruited patients will receive treatment accordingly. For analysis, the percentage change in serum potassium levels in mEq/L after each event of potassium replacement in both arms will be used as an end point to compare the efficacy EPR and IVPR for treatment of hypokalaemia.

Study setting

The study will be conducted at the PCICU at the Aga Khan University Hospital, Karachi.

Ethics and dissemination

This study has been approved by the Ethics Review Committee and Clinical Trials Unit at The Aga Khan University with respect to scientific content and compliance with applicable research and human subjects regulations.

Trial registration number

This trial is registered at Clinical Trials.Gov. Registration number: NCT02015962.

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<![CDATA[Prognostication in critically ill patients with severe traumatic brain injury: the TBI-Prognosis multicentre feasibility study]]> https://www.researchpad.co/article/5bf50de3d5eed0c48486139e

Objective

Severe traumatic brain injury is a significant cause of morbidity and mortality in young adults. Assessing long-term neurological outcome after such injury is difficult and often characterised by uncertainty. The objective of this feasibility study was to establish the feasibility of conducting a large, multicentre prospective study to develop a prognostic model of long-term neurological outcome in critically ill patients with severe traumatic brain injury.

Design

A prospective cohort study.

Setting

9 Canadian intensive care units enrolled patients suffering from acute severe traumatic brain injury. Clinical, biological, radiological and electrophysiological data were systematically collected during the first week in the intensive care unit. Mortality and functional outcome (Glasgow Outcome Scale extended) were assessed on hospital discharge, and then 3, 6 and 12 months following injury.

Outcomes

The compliance to protocolised test procedures was the primary outcome. Secondary outcomes were enrolment rate and compliance to follow-up.

Results

We successfully enrolled 50 patients over a 12-month period. Most patients were male (80%), with a median age of 45 years (IQR 29.0–60.0), a median Injury Severity Score of 38 (IQR 25–50) and a Glasgow Coma Scale of 6 (IQR 3–7). Mortality was 38% (19/50) and most deaths occurred following a decision to withdraw life-sustaining therapies (18/19). The main reasons for non-enrolment were the time window for inclusion being after regular working hours (35%, n=23) and oversight (24%, n=16). Compliance with protocolised test procedures ranged from 92% to 100% and enrolment rate was 43%. No patients were lost to follow-up at 6 months and 2 were at 12 months.

Conclusions

In this multicentre prospective feasibility study, we achieved feasibility objectives pertaining to compliance to test, enrolment and follow-up. We conclude that the TBI-Prognosis prospective multicentre study in severe traumatic brain injury patients in Canada is feasible.

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<![CDATA[Multicentre randomised controlled trial to investigate the usefulness of continuous pneumatic regulation of tracheal cuff pressure for reducing ventilator-associated pneumonia in mechanically ventilated severe trauma patients: the AGATE study protocol]]> https://www.researchpad.co/article/5b46adbe463d7e62a95cbecd

Introduction

Severe trauma represents the leading cause of mortality worldwide. While 80% of deaths occur within the first 24 hours after trauma, 20% occur later and are mainly due to healthcare-associated infections, including ventilator-associated pneumonia (VAP). Preventing underinflation of the tracheal cuff is recommended to reduce microaspiration, which plays a major role in the pathogenesis of VAP. Automatic devices facilitate the regulation of tracheal cuff pressure, and their implementation has the potential to reduce VAP. The objective of this work is to determine whether continuous regulation of tracheal cuff pressure using a pneumatic device reduces the incidence of VAP compared with intermittent control in severe trauma patients.

Methods and analysis

This multicentre randomised controlled and open-label trial will include patients suffering from severe trauma who are admitted within the first 24 hours, who require invasive mechanical ventilation to longer than 48 hours. Their tracheal cuff pressure will be monitored either once every 8 hours (control group) or continuously using a pneumatic device (intervention group). The primary end point is the proportion of patients that develop VAP in the intensive care unit (ICU) at day 28. The secondary end points include the proportion of patients that develop VAP in the ICU, early (≤7 days) or late (>7 days) VAP, time until the first VAP diagnosis, the number of ventilator-free days and antibiotic-free days, the length of stay in the ICU, the proportion of patients with ventilator-associated events and that die during their ICU stay.

Ethics and dissemination

This protocol has been approved by the ethics committee of Poitiers University Hospital, and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.

Trial registration

Clinical Trials NCT02534974

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<![CDATA[Study protocol for a randomised controlled trial comparing the efficiency of two provider-endorsed manual paediatric fluid resuscitation techniques]]> https://www.researchpad.co/article/5acc8844463d7e4524cc252f

Introduction

Paediatric shock is a life-threatening condition with many possible causes and a global impact. Current resuscitation guidelines require rapid fluid administration as a cornerstone of paediatric shock management. However, little evidence is available to inform clinicians how to most effectively perform rapid fluid administration where this is clinically required, resulting in suboptimal knowledge translation of current resuscitation guidelines into clinical practice.

Objectives

This study aims to determine which of the two commonly used techniques for paediatric fluid resuscitation (disconnect–reconnect technique and push–pull technique) yields a higher fluid administration rate in a simulated clinical scenario. Secondary objectives include determination of catheter dislodgement rates, subjective and objective measures of provider fatiguability and descriptive information regarding any technical issues encountered with performance of each method under the study.

Methods and analysis

This study will utilise a randomised crossover trial design. Participants will include consenting healthcare providers from McMaster Children's Hospital. Each participant will administer 900 ml (60 ml/kg) of normal saline to a simulated 15 kg infant as quickly as possible on two separate occasions using the manual fluid administration techniques under the study. The primary outcome, rate of fluid administration, will be evaluated using a paired two-tailed Student t test.

Ethics and dissemination

This protocol has been approved by the Hamilton Health Sciences Research Ethics Board.

Results

These will be published in a peer-reviewed scientific journal and presented at one or more scientific conferences.

Protocol Registration

Protocol Registered on ClinicalTrials.gov NCT01774214

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<![CDATA[Protocol for a feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients]]> https://www.researchpad.co/article/5c6446cfd5eed0c484c2c4d5

Introduction

Oxygen is the most commonly administered drug to mechanically ventilated critically ill adults, yet little is known about the optimum oxygen saturation (SpO2) target for these patients; the current standard of care is an SpO2 of 96% or above. Small pilot studies have demonstrated that permissive hypoxaemia (aiming for a lower SpO2 than normal by using a lower fractional inspired oxygen concentration (FIO2)) can be achieved in the critically ill and appears to be safe. This approach has not been evaluated in a National Health Service setting. It is possible that permissive hypoxaemia may be beneficial to critically ill patients thus it requires robust evaluation.

Methods and analysis

Targeted OXygen therapY in Critical illness (TOXYC) is a feasibility randomised controlled trial (RCT) to evaluate whether recruiting patients to a study of permissive hypoxaemia is possible in the UK. It will also investigate biological mechanisms that may underlie the links between oxygenation and patient outcomes. Mechanically ventilated patients with respiratory failure will be recruited from critical care units at two sites and randomised (1:1 ratio) to an SpO2 target of either 88%–92% or ≥96% while intubated with an endotracheal tube. Clinical teams can adjust FIO2 and ventilator settings as they wish to achieve these targets. Clinical information will be collected before, during and after the intervention and blood samples taken to measure markers of systemic oxidative stress. The primary outcome of this study is feasibility, which will be assessed by recruitment rate, protocol adherence and withdrawal rates. Secondary outcomes will include a comparison of standard critical care outcome measures between the two intervention groups, and the measurement of biomarkers of systemic oxidative stress. The results will be used to calculate a sample size, likely number of sites and overall length of time required for a subsequent large multicentre RCT.

Ethics and dissemination

This study was approved by the London - Harrow Research Ethics Committee on 2 November 2017 (REC Reference 17/LO/1334) and received HRA approval on 13 November 2017. Results from this study will be disseminated in peer-reviewed journals, at medical and scientific meetings, in the NIHR Journals Library and patient information websites.

Trial registration number

NCT03287466; Pre-results.

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<![CDATA[Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients’ delirium and related outcomes]]> https://www.researchpad.co/article/5c6446bdd5eed0c484c2c3d4

Introduction

Delirium is a common complication of critical illness, associated with negative patient outcomes. Preventive or therapeutic interventions are mostly ineffective. Although relaxation-inducing approaches may benefit critically ill patients, no well-designed studies target delirium prevention as a primary outcome. The objective of this study is to assess feasibility and treatment effect estimates of a multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage for prevention of critical illness delirium and for related outcomes.

Methods and analysis

Randomised, controlled, single-blinded trial with two parallel groups (1:1 allocation: intervention and standard care) and stratified randomisation (age (18–64 years and ≥65 years) and presence of trauma) with blocking, involving 104 patients with Intensive Care Delirium Screening Checklist (ICDSC): 0–3 recruited from two academic intensive care units (ICUs). Intervention group participants receive the intervention in addition to standard care for up to five consecutive days (or until transfer/discharge); control group participants receive standard care and a sham intervention. We will assess predefined feasibility outcomes, that is, recruitment rates and protocol adherence. The primary clinical outcome is incidence of delirium (ICDSC ≥4). Secondary outcomes include pain scores, inflammatory biomarkers, heart rate variability, stress and quality of life (6 weeks and 4 months) post-ICU discharge. Feasibility measures will be analysed descriptively, and outcomes will be analysed longitudinally. Estimates of effects will be calculated.

Ethics and dissemination

The study has received approval from the Human Research Ethics Board, University of Alberta. Results will inform the design of a future multicentre trial.

Trial registration number

NCT02905812; Pre-results.

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<![CDATA[Lung protective ventilation in patients undergoing major surgery: a systematic review protocol]]> https://www.researchpad.co/article/5ad33a87463d7e7e2aff86f5

Introduction

There is growing interest in the use of low tidal volume ventilation in patients undergoing general anaesthesia. However, its potential benefit has long been debated and conflicting results have been reported. We describe here the protocol of a systematic review and meta-analysis for investigating the beneficial effects of low tidal volume ventilation in patients undergoing general anaesthesia.

Methods and analysis

Data sources include PubMed, Scopus, Embase and EBSCO. Patients undergoing general anaesthesia will be included irrespective of type of surgery. The intervention is low tidal volume ventilation or protective ventilation, and the control is conventional ventilation. The quality of included trials will be assessed by using Delphi consensus. Outcomes include new onset lung injury, atelectasis, arrhythmia, levels of inflammatory biomarkers, arterial oxygenation, partial pressure of carbon dioxide and alveolar–arterial oxygen gradient. Conventional approaches for meta-analysis will be used, and heterogeneity will be investigated by using subgroup analysis and meta-regression if appropriate. The Bayesian method will be used for the synthesis of binary outcome data.

Ethics and dissemination

The systematic review was approved by the ethics committee of Jinhua hospital of Zhejiang university and will be published in a peer-reviewed journal and will be disseminated electronically and in print.

Registration details

The study protocol has been registered in PROSPERO (http://www.crd.york.ac.uk/PROSPERO/) under registration number CRD42013006416.

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