Comparison of Continuous Positive Airway Pressure (CPAP) With Autoadjusting CPAP in the Treatment of Obstructive Sleep Apnea (OSA) in the Postoperative Setting

This study has been terminated.
(Difficulty with enrollment)
Sponsor:
Collaborators:
ResMed
Great Lakes NeuroTechnologies Inc.
Information provided by (Responsible Party):
Dennis Auckley, MD, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00588848
First received: January 3, 2008
Last updated: July 18, 2013
Last verified: July 2013

January 3, 2008
July 18, 2013
January 2008
April 2011   (final data collection date for primary outcome measure)
Sleep Related Hypoxemia [ Time Frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. ] [ Designated as safety issue: No ]
Sleep related Hypoxemia [ Time Frame: During the night of the study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00588848 on ClinicalTrials.gov Archive Site
  • Apnea-Hypopnea Index (AHI) [ Time Frame: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission. ] [ Designated as safety issue: No ]
    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 Complications [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Apnea-hypopnea Index [ Time Frame: During the night of the study ] [ Designated as safety issue: No ]
  • Cardiopulmonary complications [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of Continuous Positive Airway Pressure (CPAP) With Autoadjusting CPAP in the Treatment of Obstructive Sleep Apnea (OSA) in the Postoperative Setting
Postoperative Management of Obstructive Sleep Apnea With CPAP vs. an Autoadjusting CPAP Device: a Randomized Controlled Single Center Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obstructive Sleep Apnea
  • Device: Autoadjusting CPAP (VPAP Auto)
    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).
    Other Name: VPAP Auto
  • Device: CPAP
    Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)
  • Experimental: 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.
    Intervention: Device: Autoadjusting CPAP (VPAP Auto)
  • Active Comparator: CPAP arm (usual care)
    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.
    Intervention: Device: CPAP

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588848
IRB07-00504
No
Dennis Auckley, MD, MetroHealth Medical Center
MetroHealth Medical Center
  • ResMed
  • Great Lakes NeuroTechnologies Inc.
Principal Investigator: Inderjeet S Brar, MD MetroHealth Medical Center, Case Western Reserve University
Principal Investigator: Dennis Auckley, MD MetroHealth Medical Center, Case Western Reserve University
MetroHealth Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP