Mechanical Ventilation Complication Clinical Trial
— PEDIASEDOfficial 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.
NCT number | NCT02040168 |
Other study ID # | PROG/10/53 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2010 |
Est. completion date | October 31, 2015 |
Verified date | September 2021 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 106 |
Est. completion date | October 31, 2015 |
Est. primary completion date | December 31, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Nantes University Hospital | Nantes | Loire-Atlantique |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of the ventilation period | 30% decrease of the ventilation period | Hospitalization + 8 weeks | |
Secondary | 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 |
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