Other Clinical Trial - Reduce Pediatric Sedation to Reduce Mechanical

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Mechanical Ventilation Complication

Clinical Trial Details

NCT number	NCT02040168
Study type	Observational
Source	Nantes University Hospital
Contact
Status	Completed
Phase
Start date	October 1, 2010
Completion date	October 31, 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU — PEDIASED

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms