Improving Adherence to the Sedation-analgesia Protocol in Pediatric Intensive Care

NCT07038850 | Completed

• 1 other identifier: 69HCL18_0108
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 2

Brief Summary

Sedation-analgesia is a major concern in the management of children in pediatric intensive care units (PICUs). International guidelines recommend the use of sedation-analgesia protocols, as their implementation has already proven effective in pediatrics. However, maintaining their long-term application remains a challenge. Indeed, healthcare teams adherence to these protocols tends to decrease over time, thereby compromising their long-term impact. This study aims to evaluate the impact of multimodal nurses training on improving and sustaining adherence to sedation-analgesia protocols. This is a non-randomized, before-and-after interventional prospective study conducted in two mixed pediatric intensive care units (Lyon and Nantes). The investigators seek to evaluate sedation practices before and after the implementation of specific multimodal training for nurses on the sedation-analgesia protocol. The primary outcome is protocol adherence. Secondary outcomes include the duration of mechanical ventilation and PICU stay, the number of daily COMFORT-B score assessments, total medication doses, the incidence of ventilator-associated pneumonia, and a qualitative analysis of non-adherence factors.

Conditions

Mechanical Ventilation; Analgesia; Nurse Training

Keywords

Nurse driven sedation-analgesia protocols; Adherence to protocol; Pediatric intensive care

Outcome Measures

Primary Outcomes (1)

• Protocol adherence before and after nurse training: daily percentage of therapeutic adjustments in compliance with the sedation-analgesia protocol.

  Sedation management is considered adequate (when dose increases, decreases, or maintenance are appropriate based on the COMFORT-B score), and inadequate (when adjustments are inappropriate or if the COMFORT-B score is not recorded despite a prescribed target). Cases where no target score is prescribed are excluded from the adherence analysis.

  Compliance of therapeutic adjustments with the sedation-analgesia protocol is evaluated over the entire duration of mechanical ventilation. Daily , from initiation of mechanical ventilation until extubation

Interventions

Multimodal nurse training about nurse driven sedation-analgesia protocol OTHER

The training program for nursing staff in the use of the sedation-analgesia protocol includes 3 stages: 1. Initial training: e-learning module to be validated 2. Feedback session: sessions in small groups of 5 to 6 participants, led by a nurse trainer, allowing interprofessional transmission (questions/answers and critical analyzes of sedation collection sheets). 3. Bedside rehearsal: individual practice of the sedation-analgesia protocol at the patient's bedside under the supervision of a doctor or nurse trainer.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients aged 0 to 18 years
• admitted to the PICU
• requiring mechanical ventilation
• receiving continuous sedation for more than 24 hour

You may not qualify if:

• patients requiring mechanical ventilation for more than 15 days
• transferred from another unit where sedation had already been initiated
• patients under sedation as part of withdrawing and withholding life-sustaining treatment
• deceased patients
• preexisting tracheostomies

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Service de réanimation pédiatrique du CHU de Lyon

Lyon, 69000, France

Location

Service de réanimation pédiatrique du CHU de Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Fabienne BORDET Dr Fabienne BORDET, Doctor

  HCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 26, 2025
• Study Start: November 2, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: June 26, 2025

Record last verified: 2025-05

Locations

FR (2)