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NCT00142766 · ClinicalTrials.gov registry record · Phase 2
Sedation Management in Pediatric Patients Supported on Mechanical Ventilation
A Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 245
- Enrollment target
NCT00142766 is a Phase 2 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 245 participants.
The verdict
NCT00142766, a Phase 2 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 245 participants
- Enrollment target
Study Summary
The purpose of this two-year project is to pilot test an intervention to change sedation management in pediatric patients supported on mechanical ventilation for acute respiratory failure in the pediatric intensive care unit (PICU). While ensuring patient comfort is an integral part of pediatric critical care, analgesic and sedative use in this patient population is associated with injury; specifically, comfort medications may depress spontaneous ventilation and prolong the duration of mechanical ventilation. Additionally, drug tolerance develops over time and may precipitate iatrogenic abstinence syndrome (chemical withdrawal) when the patient no longer requires sedation. Alternatively, suboptimal comfort management contributes to the patient not breathing synchronously with the ventilator and/or self-removal of breathing tubes. Our group has developed and validated a nurse-implemented sedation algorithm (set of specific instructions) to guide titration of comfort medications that may optimize patient comfort and reduce the risk of under-medication, but this algorithm needs to be evaluated further. We hypothesize that pediatric patients managed per sedation protocol will experience fewer days of mechanical ventilation than patients receiving usual care. This research has the potential of revolutionizing sedation practices that are driven by and synchronized to patient needs.
Interventions
- BEHAVIORAL Nurse Implemented Goal-Directed Comfort Algorithm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2004-02 |
| Est. Completion | 2007-03 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00142766
The ClinicalTrials.gov registry entry for NCT00142766 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nurse Implemented Goal-Directed Comfort Algorithm is the first listed.
NCT00142766 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00142766 about?
NCT00142766 is a clinical study titled "Sedation Management in Pediatric Patients Supported on Mechanical Ventilation". The purpose of this two-year project is to pilot test an intervention to change sedation management in pediatric patients supported on mechanical ventilation for acute respiratory failure in the pediatric intensive care unit (PICU). While ensuring patient comfort is an integral part of pediatric cri...
What is the current status of trial NCT00142766?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 245 participants. The study started on 2004-02. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00142766?
The interventions under investigation include: Nurse Implemented Goal-Directed Comfort Algorithm (BEHAVIORAL).
Who is sponsoring clinical trial NCT00142766?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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