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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
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Description
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Brief Summary:
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 or disease
Obstructive Sleep Apnea

Detailed Description:
There is no further detailed description available.
Study Design
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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

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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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
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
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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


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