Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea
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ClinicalTrials.gov Identifier: NCT01078207 |
Recruitment Status :
Completed
First Posted : March 2, 2010
Results First Posted : August 1, 2012
Last Update Posted : August 7, 2014
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Condition or disease |
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Obstructive Sleep Apnea |
Study Type : | Observational |
Actual Enrollment : | 100 participants |
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 |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | October 2010 |

- 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
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078207
Canada, Ontario | |
Toronto General Hospital | |
Toronto, Ontario, Canada, M5G 2C4 | |
Toronto Western Hospital | |
Toronto, Ontario, Canada, M5T2S8 |
Study Chair: | Roger Mecca, MD | Medtronic - MITG |
Responsible Party: | Medtronic - MITG |
ClinicalTrials.gov Identifier: | NCT01078207 |
Other Study ID Numbers: |
COV-MO-PO-A105 |
First Posted: | March 2, 2010 Key Record Dates |
Results First Posted: | August 1, 2012 |
Last Update Posted: | August 7, 2014 |
Last Verified: | August 2014 |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |