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

Not Applicable

Completed

• Conditions: Mechanical Ventilation; Analgesia; Nurse Training

• Registration Number: NCT07038850
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-02
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (2)

Service de réanimation pédiatrique du CHU de Lyon; 🇫🇷 Lyon, France

Service de réanimation pédiatrique du CHU de Nantes; 🇫🇷 Nantes, France