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

MetroHealth Medical Center

Status: Terminated

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP; Device: Autoadjusting CPAP (VPAP Auto)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00588848

IRB07-00504

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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11 participants in 2 patient groups

Autoadjusting CPAP (VPAP auto)

Experimental group

Description:

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.

Treatment:

Device: Autoadjusting CPAP (VPAP Auto)

CPAP arm (usual care)

Active Comparator group

Description:

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.

Treatment:

Device: CPAP