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

NCT01078207 | Completed Results DMC

• 1 other identifier: COV-MO-PO-A105
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.

  Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects

  12 hour after released from the recovery room

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (2)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Fran Haury, RRT Research Coordinator, Clinical Affairs
• Organization: Covidien

fran.haury@covidien.com

303 305-2314

Study Officials

• Roger Mecca, MD

  Medtronic - MITG

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 2, 2010
• Study Start: January 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 7, 2014
• Results First Posted: August 1, 2012

Record last verified: 2014-08

Locations

CA (2)