Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea
This study has been completed.
Information provided by (Responsible Party):
First received: February 26, 2010
Last updated: June 27, 2012
Last verified: June 2012
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.
||Observational Model: Case Control
Time Perspective: Prospective
||A Prospective Non-Randomized Study of Pulse Oximetry Saturation Patterns in Postoperative Patients at High Risk of Obstructive Sleep Apnea
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2010 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery.
- 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
- 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
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 ClinicalTrials.gov identifier: NCT01078207
|Toronto Western Hospital
|Toronto, Ontario, Canada, M5T2S8 |
|Toronto General Hospital
|Toronto, Ontario, Canada, M5G 2C4 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 26, 2010
|Results First Received:
||May 14, 2012
||June 27, 2012
||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:
ClinicalTrials.gov processed this record on August 01, 2014
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Nervous System Diseases