Implementation of a New Analgesia-sedation Algorithm in the Pediatric Intensive Care Unit to Reduce Overall Benzodiazepine Usage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 680
- 试验地点
- 1
- 主要终点
- Benzodiazepine exposure
研究概览
简要总结
The purpose of the study is to develop and implement an evidence-based analgesia-sedation algorithm in the pediatric intensive care unit (PICU) using quality improvement and implementation science methodology. The analgesia-sedation protocol will be implemented for patients admitted to the pediatric ICU who require mechanical ventilation for greater than 24 hours. Specifically, we will examine the impact of this implementation on total benzodiazepine usage, ICU length of stay, and ventilator free days, using a pre- and post- algorithm implementation comparative design.
详细描述
Study Design and exposures:
- Development of an evidence-based analgesia-sedation algorithm for mechanically ventilated children using an iterative, multidisciplinary collaborative effort.
- Exposure: Implementation of the analgesia-sedation algorithm using standard quality improvement (QI) methodology. This will include education, awareness, wash-in phases followed by actual implementation with support. We will use a before-after comparison design.
Patients will be eligible if they are admitted to the medical and multidisciplinary (medical/surgical) ICUs at Boston Children's Hospital and require mechanical ventilatory support for greater than 24 hours.
Study period: Eligible patients who are admitted to the ICUs between August 1st 2017 - February 28th 2018 (pre-implementation) and August 1st 2019 - February 28th 2020 (post-implementation) will be enrolled.
Data collection: Retrospective chart review, with manual data entry in REDCap. Pre-intervention data will be collected starting July 2019. After the intervention begins in July 2019, data collection will occur monthly with the intent of collecting compliance data through analyzing usage of a new electronic medical record order set designed specifically for this intervention and feeding that back to staff members via electronic communication and meeting presentations in order to assess barriers to implementation of the new algorithm. Prospective post-intervention data collection will begin in September 2019 and end in March 2020.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the pediatric ICU between August 1st 2017 - February 28th 2018 and August 1st 2019 - February 28th 2020
- •Intubated for greater than 24 hours will be eligible
排除标准
- •Ventilated via a tracheostomy at the time of admission
- •Pre-admission documentation of dexmedetomidine allergy
- •Receiving a midazolam infusion for greater than 4 hours at the time of admission
- •Admitted to the ICU for initiation of the rapid-escalation midazolam protocol for status epilepticus
结局指标
主要结局
Benzodiazepine exposure
时间窗: We will collect data (after hospital discharge) on amount of benzodiazepine administration in their ICU stay for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
Total exposure of benzodiazepines (midazolam, lorazepam, diazepam) measured per kilogram of weight over the patient's duration of ICU stay.
次要结局
- ICU length of stay(We will collect data (after hospital discharge) on duration of ICU stay for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).)
- Ventilator free days(We will collect data (after hospital discharge) on duration of intubation for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).)
- Opioid exposure(We will collect data (after hospital discharge) on amount of opioid administration in their ICU stay for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).)
- Adverse events(We will collect data (after hospital discharge) on morbidity events for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).)
- State behavioral scale (SBS) scores(We will collect data (after hospital discharge) on documented SBS scores for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).)
- Cornell Assessment of Pediatric Delirium (CAPD) scores(We will collect data (after hospital discharge) on documented CAPD scores for each ICU patient admitted between Aug 2019 - Feb 2020 (post-intervention group only).)
研究者
Nilesh M. Mehta
Professor of Anaesthesia, Critical Care, Harvard Medical School
Boston Children's Hospital