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Comparison of CPAP With Autoadjusting CPAP in the Treatment of 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: October 23, 2012
Last verified: October 2012
History of Changes
  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 Continuous Positive Airway Pressure (VPAP Auto)
Device: Continuous Positive Airway Pressure (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:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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 [ 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 ]
  • 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: AUTOCPAP
An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)
 Device: Autoadjusting Continuous Positive Airway Pressure (VPAP Auto)
An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery).
Other Name: VPAP Auto
Active Comparator: CPAP
Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)
 Device: Continuous Positive Airway Pressure (CPAP)
Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)

  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. SaO2 ≥ 89% and post-treatment 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-PAP
  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 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
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
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:
OSAHS
OSA
Postoperative
CPAP

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

ClinicalTrials.gov processed this record on May 19, 2013