Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU

NCT02040168 | Completed

• 1 other identifier: PROG/10/53
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication

Keywords

Ventilation; PTSD; sedation

Outcome Measures

Primary Outcomes (1)

• Duration of the ventilation period

  30% decrease of the ventilation period

  Hospitalization + 8 weeks

Secondary Outcomes (1)

• evaluate the impact of sedation protocol on short-term consequences of prolonged sedation

  Hospitalization + 8 weeks

Study Arms (2)

28 days - 18 yo

Children requiring mechanical ventilation for at least 24h from 28 days to 18 yo

18 months - 18 yo

Post traumatic stress disorder evaluation in children requiring mechanical ventilation for at least 24h from 18 month to 18 Years old

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The old children from 28 days to 18 years admitted in pediatric intensive care unit of Nantes University Hospital requiring mechanical ventilation for at least 24 hours can be included in this study.

You may qualify if:

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

You may not qualify if:

• Sedation started in another intensive care unit \> 24 hours

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

MeSH Terms

Conditions

Respiratory Aspiration; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Liet Jean Michel

  Nantes UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: January 20, 2014
• Study Start: October 1, 2010
• Primary Completion: December 31, 2014
• Study Completion: October 31, 2015
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

FR (1)