Expired Study
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Cleveland, Ohio 44109


Purpose:

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 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. 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.


Criteria:

Inclusion Criteria: 1. 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 2. Elective extremity or lower abdominal surgery 3. Age >18 years Exclusion Criteria: 1. 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. 2. Surgery on the upper-airway. 3. Any condition that may interfere with application of CPAP mask e.g. trauma, surgery on the face, vomiting, naso-gastric intubation etc. 4. OSA treated with a device other than CPAP e.g. Bilevel positive pressure or V-Positive Airway Pressure 5. OSA needing very high levels of CPAP i.e. > 16 cms to achieve adequate control 6. OSA or other underlying cardiopulmonary conditions that require supplemental oxygen 7. Patients with decompensated congestive heart failure or advanced Chronic Obstructive Pulmonary Disease (COPD) (FEV1<35% of predicted) 8. Patients with neuromuscular impairment 9. Patients with central sleep apnea 10. Pregnant patients 11. Decisional impaired subjects who are not able to consent


NCT ID:

NCT00588848


Primary Contact:

Principal Investigator
Inderjeet S Brar, MD
MetroHealth Medical Center, Case Western Reserve University


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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