Comparison of Continuous Positive Airway Pressure (CPAP) With Autoadjusting CPAP in the Treatment of Obstructive Sleep Apnea (OSA) in the Postoperative Setting
|ClinicalTrials.gov Identifier: NCT00588848|
Recruitment Status : Terminated (Difficulty with enrollment)
First Posted : January 9, 2008
Results First Posted : May 27, 2013
Last Update Posted : July 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Autoadjusting CPAP (VPAP Auto) Device: CPAP||Not Applicable|
The purpose of this study is to determine if an Autoadjusting CPAP machine is better than the regular CPAP machine in treatment of Obstructive Sleep Apnea in the postoperative setting.
Patients with known Obstructive Sleep Apnea who are on CPAP therapy at home and undergo an elective surgery (meeting specified inclusion and exclusion criteria) will be randomized to either using Autoadjusting CPAP vs their usual CPAP at their prescribed settings the night after surgery. During that night, they will be monitored with full polysomnography in their hospital bed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Postoperative Management of Obstructive Sleep Apnea With CPAP vs. an Autoadjusting CPAP Device: a Randomized Controlled Single Center Trial|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Experimental: Autoadjusting CPAP (VPAP auto)
The intervention will be the use of an Autoadjusting CPAP unit that will be applied to the subject during the 8 hours overnight the first night after surgery (study night). During this time, they will undergo a full night attended polysomnogram in their hospital room.
Device: Autoadjusting CPAP (VPAP Auto)
An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the polysomnography study (the first night after surgery).
Other Name: VPAP Auto
Active Comparator: CPAP arm (usual care)
The intervention will be the use of the subject's own CPAP machine and this will be applied to the subject during the 8 hours overnight the first after surgery (study night). During the study night, they will undergo full polysomnography in their hospital room.
Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)
- Sleep Related Hypoxemia [ Time Frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. ]
- Apnea-Hypopnea Index (AHI) [ Time Frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. ]Events are defined as apneas and hypopneas. AHI values are typically categorized as 5-14.9 events/hr = mild; 15-29.9 events/hr = moderate; and >= 30 events/hr = severe
- Cardiopulmonary Complications [ Time Frame: 72 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588848
|United States, Ohio|
|MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Principal Investigator:||Inderjeet S Brar, MD||MetroHealth Medical Center, Case Western Reserve University|
|Principal Investigator:||Dennis Auckley, MD||MetroHealth Medical Center, Case Western Reserve University|