CPAP vs AutoCPAP for Treatment of Obstructive Sleep Apnea (OSA) in the Postoperative Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Postoperative Management of Obstructive Sleep Apnea With CPAP vs. an Autoadjusting CPAP Device: a Randomized Controlled Single Center Trial

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Autoadjusting CPAP (VPAP Auto)
* Device: CPAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autoadjusting CPAP (VPAP auto)<br>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)<br>* 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).<br>* Other names: VPAP Auto;|
| Active Comparator: CPAP arm (usual care)<br>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. | Device: CPAP<br>* Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Related Hypoxemia |  | 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) | 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 | On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. | 
| Cardiopulmonary Complications | Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea Hypopnea Syndrome, OSA, Postoperative, CPAP