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

This study has been completed.
Information provided by (Responsible Party):
Medtronic - MITG Identifier:
First received: February 26, 2010
Last updated: August 5, 2014
Last verified: August 2014
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.

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:

Further study details as provided by Medtronic - MITG:

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 ]
    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 ]
    The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors.

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)
Detailed Description:
There is no further detailed description available.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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
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 identifier: NCT01078207

Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
Medtronic - MITG
Study Chair: Roger Mecca, MD Medtronic - MITG
  More Information

Responsible Party: Medtronic - MITG 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: August 5, 2014

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on August 18, 2017