Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU

NCT ID: NCT02040168

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-01
• Study Completion Date: 2015-10-31

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

Conditions

Mechanical Ventilation Complication

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

28 days - 18 yo

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liet Jean Michel

Role: PRINCIPAL_INVESTIGATOR

Nantes UH

Locations

Nantes University Hospital

Nantes, Loire-Atlantique, France

Countries

France

Other Identifiers

PROG/10/53

Identifier Type: -

Identifier Source: org_study_id