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

Improving Caregivers' Adherence to a Sedation-analgesia Protocol Managed by Pediatric Intensive Care Nurses: a Quality Approach Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07038850
Acronym
SEDATIDE2
Enrollment
285
Registered
2025-06-26
Start date
2020-11-02
Completion date
2023-03-31
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Mechanical Ventilation, Nurse Training

Keywords

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

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.

Interventions

OTHERMultimodal 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 extubationSedation 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026