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Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
The Cleveland Clinic
Johns Hopkins University
Information provided by:
Cleveland Medical Devices Inc
ClinicalTrials.gov Identifier:
NCT00922168
First received: June 15, 2009
Last updated: June 10, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.


Condition
Sleep Disordered Breathing
Obstructive Sleep Apnea
Central Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pre-operative PSG Assessment of Cardiac Surgery Inpatients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cleveland Medical Devices Inc:

Primary Outcome Measures:
  • Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients [ Time Frame: September 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess Post-Operative Complications of Patients with Sleep Disordered Breathing [ Time Frame: September 2009 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: March 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac Surgeries: CABG, valve replacements

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

cardiac surgery patients

Criteria

Inclusion Criteria:

  • Subjects undergoing major cardiovascular surgery (coronary artery bypass graft, valve replacement surgery, or aortic surgery) under general anesthesia.
  • Subjects in whom surgery is planned for greater than 1 day but less than 60 days from the time of enrollment.

Exclusion Criteria:

  • Subjects treated for sleep apnea with positive airway pressure (PAP) therapy or oral appliance in the past 30 days.
  • Subjects undergoing Maze procedure for atrial fibrillation.
  • Subjects unable to comply with study procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922168

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Cleveland Medical Devices Inc
National Institutes of Health (NIH)
The Cleveland Clinic
Johns Hopkins University
Investigators
Principal Investigator: Hani A Kayyali, MS Cleveland Medical Devices Inc
Principal Investigator: Nancy Foldvary, DO The Cleveland Clinic
Principal Investigator: Nancy Collop, MD Johns Hopkins University
  More Information

Additional Information:
Click here for more information about Pre-operative PSG in cardiac surgery inpatients  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hani Kayyali, President, Cleveland Medical Devices Inc.
ClinicalTrials.gov Identifier: NCT00922168     History of Changes
Other Study ID Numbers: Pre-op PSG, R44NS42451
Study First Received: June 15, 2009
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cleveland Medical Devices Inc:
Sleep
apnea
obstructive
central

Additional relevant MeSH terms:
Apnea
Respiratory Aspiration
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Apnea, Central
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