Postoperative Management of Obstructive Sleep Apnea With CPAP vs. an Autoadjusting CPAP Device: a Randomized Controlled Single Center Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- MetroHealth Medical Center
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Sleep Related Hypoxemia
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Dennis Auckley, MD
Associate Professor of Medicine, CWRU
MetroHealth Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Sleep Related Hypoxemia
Time Frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
Secondary Outcomes
- Apnea-Hypopnea Index (AHI)(On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.)
- Cardiopulmonary Complications(72 hours)