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
  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.


Condition Intervention
Obstructive Sleep Apnea
Device: Autoadjusting CPAP (VPAP Auto)
Device: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Management of Obstructive Sleep Apnea With CPAP vs. an Autoadjusting CPAP Device: a Randomized Controlled Single Center Trial

Resource links provided by NLM:


Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: January 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Device: CPAP
Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588848

Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
ResMed
Great Lakes NeuroTechnologies Inc.
Investigators
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
  More Information

Publications:
Responsible Party: Dennis Auckley, MD, Associate Professor of Medicine, CWRU, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00588848     History of Changes
Other Study ID Numbers: IRB07-00504
Study First Received: January 3, 2008
Results First Received: October 28, 2012
Last Updated: July 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:
Obstructive Sleep Apnea Hypopnea Syndrome
OSA
Postoperative
CPAP

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014