Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU

Completed

• Conditions: Mechanical Ventilation Complication

• Registration Number: NCT02040168
• Lead Sponsor: Nantes University Hospital

Brief Summary

Mechanical ventilation is a common procedure used in pediatric intensive care units (ICU). Its use requires almost always the establishment of a sedation. Sedation is a generic term for all procedures, pharmacological or not, ensuring physical and psychological comfort and the safety of patient admitted in intensive care units.

An inadequate sedation, insufficient or excessive, has common side effects, as increase of the duration of mechanical ventilation and of hospital-acquired infections (in particular, ventilator associated pneumonia), of hemodynamic disorders, of extubation failure or accidental extubation, of withdrawal syndrome, and of post-traumatic stress disorder (PTSD). All these complications increase mechanical ventilation time and ICU length of stay. Several studies in adult's population have shown that the implementation of a sedation algorithm allowed to decrease the incidence of these complications.

We hypothetized that the duration of mechanical ventilation would be reduced by a nurse-implemented sedative management protocol.

Detailed Description

1. During the first period (15 months), no protocol is used. This period consists to assess current analgesia-sedation procedure used in the pediatric intensive care unit (PICU), associated with the collection of medical and socio-demographical data about mechanical ventilation duration, sedation complications, PTSD development. The severity of pathology can be evaluated using PIM2 and POPC scores. The sedation deepness will be determined using COMFORT-B scale. Eight weeks after hospitalization, families will be phoned to assess children memories, anxious troubles, and PTSD symptoms for the patients of more than 18 months old.

2. During the transition period (6 months), nurses and physicians develop the protocol and undergo training in its use.

During the third period, a nurse-implemented sedation is used. The collected data are the same that the collected data during the first period

Study Timeline

• Study Start: 2010-10-01
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-20
• Primary Completion: 2014-12-31
• Study Completion: 2015-10-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Children aged 28 days to 18 years
• Admitted in pediatric intensive care unit
• Necessity of mechanical ventilation > 24 hours.

Exclusion Criteria

• Sedation started in another intensive care unit > 24 hours

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of the ventilation period	Hospitalization + 8 weeks	30% decrease of the ventilation period

Secondary Outcome Measures

Name	Time	Method
evaluate the impact of sedation protocol on short-term consequences of prolonged sedation	Hospitalization + 8 weeks	Hospitalization length reduction PTSD incidence reduction of 50% Weaning syndrom incidence decrease Sedation drugs total dose decrease Decrease of mechanical ventilation related infections Decrease of accidental or self extubation frequency Required amine total dose decrease Correlation between sedation level and PTSD frequency Analysis of PTSD risk factors

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France