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

Not Applicable
Terminated
Conditions
Obstructive Sleep Apnea
Interventions
Device: Autoadjusting CPAP (VPAP Auto)
Device: CPAP
Registration Number
NCT00588848
Lead Sponsor
MetroHealth Medical Center
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
11
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Autoadjusting CPAP (VPAP auto)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.
CPAP arm (usual care)CPAPThe 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.
Primary Outcome Measures
NameTimeMethod
Sleep Related HypoxemiaOn postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
Secondary Outcome Measures
NameTimeMethod
Apnea-Hypopnea Index (AHI)On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.

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

Cardiopulmonary Complications72 hours

Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke

Trial Locations

Locations (1)

MetroHealth Medical Center

🇺🇸

Cleveland, Ohio, United States

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