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

Boston Children's Hospital

Status: Completed

Conditions: Sedation; Mechanical Ventilation

Treatments: Other: Analgesia-Sedation algorithm

Study type: Observational

Funder types: Other

Identifiers

NCT04263662

IRB-P00032707

Details and patient eligibility

About

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.

Full 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.

Enrollment: 680 patients

Sex: All

Ages: Under 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

680 participants in 2 patient groups

Pre-algorithm

Description:

Patients admitted to the pediatric ICU who are intubated for greater than 24 hours prior to implementation of an analgesia-sedation algorithm.

Post-algorithm

Description:

Patients admitted to the pediatric ICU who are intubated for greater than 24 hours after implementation of an analgesia-sedation algorithm.

Treatment:

Other: Analgesia-Sedation algorithm