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Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02040168
Acronym
PEDIASED
Enrollment
106
Registered
2014-01-20
Start date
2010-10-01
Completion date
2015-10-31
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication

Keywords

Ventilation, PTSD, sedation

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

Interventions

None listed

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
28 Days to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of the ventilation periodHospitalization + 8 weeks30% decrease of the ventilation period

Secondary

MeasureTime frameDescription
evaluate the impact of sedation protocol on short-term consequences of prolonged sedationHospitalization + 8 weeksHospitalization 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026