Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU

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.

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Key information

Conditions

Mechanical Ventilation Complication Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

28 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

About this study

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.
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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Duration of the ventilation period

Time frame: Hospitalization + 8 weeks

30% decrease of the ventilation period

Secondary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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.

Acronym: PEDIASED

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2015
First posted: Jan 20, 2014
Registry last updated: Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed