Dataset Information

Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial.

ABSTRACT: BACKGROUND:Despite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding. Stress ulcer prophylaxis may have unintended consequences-increasing the risk of nosocomial infections-which may be more serious and common than the bleeding which these drugs are prescribed to prevent. Randomized controlled trials (RCTs) in pediatric critical care are exceptionally challenging to complete, thus a rigorous pilot RCT is crucial. The objective of this pilot RCT is to assess the feasibility of a large multicentre RCT of stress ulcer prophylaxis with pantoprazole to prevent upper GI bleeding vs. placebo. METHODS:A multi-centre blinded pilot RCT of 120 children in six Canadian PICUs. Children expected to require mechanical ventilation for more than 48 h will be randomized to receive intravenous pantoprazole 1 mg/kg or identical placebo once daily until they no longer need mechanical ventilation. We have four feasibility outcomes and will consider the trial successful if we achieve:Effective screening: If >80% of eligible patients are approached for consent.Timely enrollment: if >80% of participants receive their first dose of the assigned study drug within 1 day of becoming eligible.Participant accrual: If the average monthly enrolment is two or more participants per centre per month.Protocol adherence: if >90% of doses are administered according to the protocol. DISCUSSION:There are many uncertainties about the risks and benefits of stress ulcer prophylaxis. In an era of widespread use-where clinicians prescribe prophylaxis to the more severely ill-a large, rigorous RCT is required. A trial to determine if a strategy of withholding stress ulcer prophylaxis is not inferior to a strategy of routine stress ulcer prophylaxis will be challenging. A carefully designed and implemented pilot trial is essential. TRIAL REGISTRATION:ClinicalTrials.gov:NCT02929563 (Registered October 3, 2016).

SUBMITTER: Duffett M

PROVIDER: S-EPMC5438532 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial.

Duffett Mark M Choong Karen K Foster Jennifer J Gilfoyle Elaine E Lacroix Jacques J Pai Nikhil N Thabane Lehana L Cook Deborah J DJ

Pilot and feasibility studies 20170519

<h4>Background</h4>Despite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding. Stress ulcer prophylaxis may have unintended consequences-increasing the risk of nosocomial infections-which may be more serious and common than the bleeding which these drugs are prescribed to prevent. Randomized controlled trials (RCTs) in pediatric critical care are exceptionally challenging to complete, thus a rigorous pilot ...[more]

PMID: 28533916

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Project description:IntroductionPressure ulcers (PUs) are associated with substantial health burden. Patients in intensive care units (ICUs) are at high risk for developing PU. In the absence of large randomised controlled trials (RCTs) that compare commonly known interventions for preventing PU in ICUs, uncertainty remains around the best practice strategy for PU management in adult ICUs. This study, therefore, aims to identify the most effective interventions and combinations of interventions that prevent PU in adult ICU using systematic review and network meta-analysis (NMA).Methods and analysisWe will search for all published and unpublished RCTs evaluating interventions to prevent PU compared with other PU prevention measures or with usual care in adult ICU. The primary outcomes are the incidence of PUs and PU severity in critically ill patients in ICU. The secondary outcomes include number of PUs per patient and intervention-related harms caused by the prevention intervention or intervention-related harms. All data extraction will be performed by at least two independent reviewers on the basis of a priori developed extraction form. We will evaluate the risk of bias of the included RCTs in accordance with the Cochrane Collaboration's risk of bias tool, and assess the quality of evidence using Grading of Recommendations Assessment, Development and Evaluation. A standard pairwise meta-analysis and a Bayesian NMA will be conducted to compare the efficacy of different PU prevention interventions. A surface under the cumulative ranking curve will be used to rank the probabilities of each prevention intervention for various outcomes.Ethics and disseminationThis study will not require the ethics approval as it is a review based on published studies. The findings of this study will be submitted to a peer-reviewed journal for publication. We anticipate that the results of the study will provide the evidence to inform clinicians and guideline developers on determining the best interventions for the prevention of PU in ICU patients.Prospero registration numberCRD42018085562.

Project description:Objectives: With the evolving COVID-19 pandemic and the emphasis on social distancing to decrease the spread of SARS-CoV-2 among healthcare workers (HCWs), our pediatric intensive care unit (PICU) piloted the integration of Zoom meetings into clinical rounds. We aimed to explore the feasibility of these hybrid virtual and physical clinical rounds for PICU patients. Design: Mixed quantitative and qualitative deductive thematic content analysis of narrative responses. Setting: PICU, single tertiary-care academic center. Participants: Multidisciplinary PICU HCWs. Interventions: Integration of Zoom meeting into clinical daily PICU rounds. Measurements: For the quantitative part, we gathered the details of daily PICU hybrid rounds in terms of times, number of HCWs, and type of files shared through Zoom. For the qualitative part, open-ended questions were used. Main Results: The physical round took statistically significantly less time (34.68 ± 14.842 min) as compared with the Zoom round (72.45 ± 22.59 min), p < 0.001. The most shared component in the virtual round was chest X-rays (93.5%). Thirty-one HCWs participated in focus group discussions and were included in the analysis. Some of the HCWs' perceived advantages of the hybrid rounds were enabling multidisciplinary discussions, fewer round interruptions, and practicality of virtual discussions. The perceived challenges were the difficulty of the bedside nurse attending the virtual round, decreased teaching opportunities for the trainees, and decreased interactions among the team members, especially if video streaming was not utilized. Conclusions: Multidisciplinary hybrid virtual and physical clinical rounds in the PICU were perceived as feasible by HCWs. The virtual rounds decreased the physical contact between the HCWs, which could decrease the possibility of SARS-CoV-2 spread among the treating team. Still, several components of the hybrid round should be optimized to facilitate the virtual team-members' interactions and enhance the teaching experience.

Dataset Information

Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial.

Publications

Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial.

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