Implementation of an Analgesia-sedation Algorithm in the Pediatric ICU to Reduce Benzodiazepine Use

Mechanical Ventilation Clinical Trial

Official title:

Implementation of a New Analgesia-sedation Algorithm in the Pediatric Intensive Care Unit to Reduce Overall Benzodiazepine Usage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263662
• Other study ID #: IRB-P00032707
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Study Design and exposures:

1. Development of an evidence-based analgesia-sedation algorithm for mechanically ventilated children using an iterative, multidisciplinary collaborative effort.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 25 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Mechanical Ventilation
• Sedation

Intervention

Other:
• Analgesia-Sedation algorithm
The analgesia-sedation algorithm is a suggested protocol for approach to providing analgesia and sedation to patients admitted to the pediatric ICU who are newly intubated. The approach focuses on using dexmedetomidine as the primary sedative, non-opioids as the primary analgesia, then stepwise approach to adding in adjunctives (e.g. opioids, non-benzodiazepines) with the intention of minimizing benzodiazepine exposure and utilizing minimal-dose effective analgesia/sedative dosing.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Benzodiazepine exposure	Total exposure of benzodiazepines (midazolam, lorazepam, diazepam) measured per kilogram of weight over the patient's duration of ICU stay.	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).
Secondary	Opioid exposure	Total exposure of opioids (measured in morphine equivalents) measured per kilogram of weight over the patient's duration of ICU stay.	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).
Secondary	ICU length of stay	Duration of stay in the ICU measured in days	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).
Secondary	Ventilator free days	Duration of time off of invasive mechanical ventilation during the ICU stay	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).
Secondary	Adverse events	Frequency of morbidities, e.g. unplanned extubation, failed extubation, cardiorespiratory arrest events, unintentional dislodgment of other lines/tubes, re-admission to the hospital/ICU within 24 hours of discharge/transfer.	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).
Secondary	State behavioral scale (SBS) scores	Difference between the desired SBS score and the recorded SBS score	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).
Secondary	Cornell Assessment of Pediatric Delirium (CAPD) scores	CAPD scores for patients during their ICU stay	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).