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NCT01045122 · ClinicalTrials.gov registry record · NA
Sedation in Patients at Risk for Upper Airway Collapse
A NA study, sponsored by University of Rochester.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT01045122 is a NA study that has completed, run by University of Rochester. The registered enrollment target is 15 participants.
The verdict
NCT01045122, a NA study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
Overview of Protocol: Between Subject - Repeated Measures design will be used to assess the airway response of two groups of subjects under two different sedated conditions. Each group will be comprised of six subjects and will be categorized according to their baseline profile for risk for SDB (\< 10 RDI or \> 25 RDI). Some subjects will have been prescribed continuous positive airway pressure (CPAP) therapy by their treating physician as a result of their overnight sleep study. CPAP treatment is effective in splinting the airway open and thus decreasing the incident of airway collapse during sleep. Thus, CPAP utilization will also be tracked as an independent and continuous variable as regular CPAP use has been found to be associated with increased resistance to UAC (upper airway collapse). The experimental conditions will evaluate upper airway patency and instability in response to two forms of intravenous sedation: propofol and dexmedetomidine. Subjects will be continuously monitored during each experimental condition for respiratory effort and flow, and for EEG, EMG, and ECG. Respiratory instability will first be assessed while subjects are under sedation without any airway provocation. The degree of respiratory instability will be quantified in terms of the following measurements: a modified Respiratory Disturbance Index (RDIsedated), respiratory arousals, and minute ventilation. The apneic periods will be classified by their mixture of central and obstructive components.All outcome measurements are assessed over the period of sedation which last for approximately one hour. Upper airway patency will be quantified in terms of the critical pharyngeal pressure (Pcrit) (the pressure beyond which complete upper airway collapse occurs, see background).
Interventions
- DRUG Dexmedetomidine
- DRUG Propofol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2006-12 |
| Est. Completion | 2008-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01045122
The ClinicalTrials.gov registry entry for NCT01045122 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dexmedetomidine is the first listed.
NCT01045122 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01045122 about?
NCT01045122 is a clinical study titled "Sedation in Patients at Risk for Upper Airway Collapse". Overview of Protocol: Between Subject - Repeated Measures design will be used to assess the airway response of two groups of subjects under two different sedated conditions. Each group will be comprised of six subjects and will be categorized according to their baseline profile for risk for SDB (\<...
What is the current status of trial NCT01045122?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2006-12. Estimated completion is 2008-10.
What interventions are being tested in trial NCT01045122?
The interventions under investigation include: Dexmedetomidine (DRUG), Propofol (DRUG).
Who is sponsoring clinical trial NCT01045122?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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