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

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT01078207
• Lead Sponsor: Medtronic - MITG

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.

Detailed Description

There is no further detailed description available.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2012-05-14
• Results First Submitted QC: 2012-06-27
• Results First Posted: 2012-08-01
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.	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

Name	Time	Method
Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure.	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.

Trial Locations

Locations (2)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada