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

NCT ID: NCT07038850

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2023-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

Multimodal nurse training about nurse driven sedation-analgesia protocol

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Fabienne BORDET Dr Fabienne BORDET, Doctor

Role: PRINCIPAL_INVESTIGATOR

HCL

Locations

Service de réanimation pédiatrique du CHU de Lyon

Lyon, , France

Service de réanimation pédiatrique du CHU de Nantes

Nantes, , France

Countries

France

Other Identifiers

69HCL18_0108

Identifier Type: -

Identifier Source: org_study_id