Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU (PEDIASED)

Evaluation of the Interest of a Nurse-implemented Sedation Protocol for the Reduction of the Duration of Mechanical Ventilation Complication Associated With Extended Sedation in Pediatric Intensive Care Unit.

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication

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 Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• France
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the ventilation period	30% decrease of the ventilation period	Hospitalization + 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the impact of sedation protocol on short-term consequences of prolonged sedation	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	Hospitalization + 8 weeks

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Liet Jean Michel, Nantes UH

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2010
• Primary Completion (Actual): December 31, 2014
• Study Completion (Actual): October 31, 2015

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: PTSD; sedation; Ventilation
• Other Study ID Numbers: PROG/10/53