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Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01078207
First received: February 26, 2010
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  Purpose

This study will include patients who have major surgery and are at risk for or have been diagnosed with sleep apnea. The patients will be monitored the night after surgery for repeating episodes of reduced breathing and oxygen levels. The study will determine if episodes of decreased breathing are reflected in the oxygen monitor.


Condition
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Non-Randomized Study of Pulse Oximetry Saturation Patterns in Postoperative Patients at High Risk of Obstructive Sleep Apnea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data. [ Time Frame: 12 hour after released from the recovery room ] [ Designated as safety issue: No ]
    Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects


Secondary Outcome Measures:
  • Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure. [ Time Frame: 12 hours after discharge form the recovery room ] [ Designated as safety issue: No ]
    The number of patients with a positive repetitive reduction in nasal airflow who have a positive oxygen desaturation pattern.


Enrollment: 100
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery.

Criteria

Inclusion Criteria:

  • Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery.
  • Patient must require analgesia and/or sedation postoperatively by any route (intravenous, intramuscular, oral, epidural or intrathecal) for the duration of the study
  • Postoperative patients with at least one anticipated over night stay on the general ward with a minimum length of 14 hrs.
  • Patients in the ASA category 1-4
  • Patients at high risk for obstructive sleep apnea (OSA) as identified by the STOP-Bang Questionnaire or patients previously diagnosed with OSA and not using a CPAP device. (No screening with STOP needed for these patients.)
  • Spontaneous breathing

Exclusion Criteria:

  • Age less than 18 years
  • Patients receiving or anticipated to receive postoperative positive airway pressure support
  • Previous allergic/contact reactions to adhesives
  • Patients unable to give informed consent
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078207

Locations
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Covidien
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01078207     History of Changes
Other Study ID Numbers: COV-MO-PO-A105
Study First Received: February 26, 2010
Results First Received: May 14, 2012
Last Updated: June 27, 2012
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario

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 June 13, 2013