CPAP vs AutoCPAP for Treatment of Obstructive Sleep Apnea (OSA) in the Postoperative Setting
January 11, 2019 updated by: Dennis Auckley, MD, MetroHealth Medical Center
Postoperative Management of Obstructive Sleep Apnea With CPAP vs. an Autoadjusting CPAP Device: a Randomized Controlled Single Center Trial
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Known OSA patients well-controlled by CPAP (not hypoxemic i.e. Oxygen Saturation (SaO2) ≥ 89% and post-treatment Apnea Hypopnea (AHI) <10) and compliant ( > 3 hours per night) presenting for elective inpatient surgery to MetroHealth Medical Center
- Elective extremity or lower abdominal surgery
- Age >18 years
Exclusion Criteria:
- Surgery that may cause hypoxemia from causes other than the effect on upper airway patency e.g. any thoracic surgery, upper abdominal surgery, head and neck surgery.
- Surgery on the upper-airway.
- Any condition that may interfere with application of CPAP mask e.g. trauma, surgery on the face, vomiting, naso-gastric intubation etc.
- OSA treated with a device other than CPAP e.g. Bilevel positive pressure or V-Positive Airway Pressure
- OSA needing very high levels of CPAP i.e. > 16 cms to achieve adequate control
- OSA or other underlying cardiopulmonary conditions that require supplemental oxygen
- Patients with decompensated congestive heart failure or advanced Chronic Obstructive Pulmonary Disease (COPD) (FEV1<35% of predicted)
- Patients with neuromuscular impairment
- Patients with central sleep apnea
- Pregnant patients
- Decisional impaired subjects who are not able to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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 Names:
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sleep Related Hypoxemia
Time Frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
|
On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Apnea-Hypopnea Index (AHI)
Time Frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
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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
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On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
|
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Cardiopulmonary Complications
Time Frame: 72 hours
|
Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
- Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT, Cote CJ, Nickinovich DG, Prachand V, Ward DS, Weaver EM, Ydens L, Yu S; American Society of Anesthesiologists Task Force on Perioperative Management. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2006 May;104(5):1081-93; quiz 1117-8. doi: 10.1097/00000542-200605000-00026. No abstract available.
- Ostermeier AM, Roizen MF, Hautkappe M, Klock PA, Klafta JM. Three sudden postoperative respiratory arrests associated with epidural opioids in patients with sleep apnea. Anesth Analg. 1997 Aug;85(2):452-60. doi: 10.1097/00000539-199708000-00037. No abstract available.
- Bailey PL, Pace NL, Ashburn MA, Moll JW, East KA, Stanley TH. Frequent hypoxemia and apnea after sedation with midazolam and fentanyl. Anesthesiology. 1990 Nov;73(5):826-30. doi: 10.1097/00000542-199011000-00005.
- Gupta RM, Parvizi J, Hanssen AD, Gay PC. Postoperative complications in patients with obstructive sleep apnea syndrome undergoing hip or knee replacement: a case-control study. Mayo Clin Proc. 2001 Sep;76(9):897-905. doi: 10.4065/76.9.897.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
January 3, 2008
First Submitted That Met QC Criteria
January 3, 2008
First Posted (Estimate)
January 9, 2008
Study Record Updates
Last Update Posted (Actual)
January 14, 2019
Last Update Submitted That Met QC Criteria
January 11, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB07-00504
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.