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

NCT ID: NCT01078207

Last Updated: 2014-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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There is no further detailed description available.

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger Mecca, MD

Role: STUDY_CHAIR

Medtronic - MITG

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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COV-MO-PO-A105

Identifier Type: -

Identifier Source: org_study_id

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