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Improving Adherence to the Sedation-analgesia Protocol in Pediatric Intensive Care (SEDATIDE2)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Nurse Training
Analgesia
Mechanical Ventilation

Treatments

Other: Multimodal nurse training about nurse driven sedation-analgesia protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT07038850
69HCL18_0108

Details and patient eligibility

About

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.

Enrollment

285 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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