The Association of CPAP Compliance Study

July 5, 2019 updated by: Dr. Frances Chung, University Health Network, Toronto

The Association of CPAP Compliance and Nocturnal Hypoxemia in the Perioperative Period

The purpose of this study is to evaluate the pre and postoperative CPAP compliance rate in OSA surgical patients with or without a CPAP prescription. In this study, all diagnosed OSA patients with or without a CPAP prescription will be approached for informed consent to enroll in the study. Documented OSA is defined as an OSA diagnosis based on a previous laboratory or portable PSG, or on the prescription of CPAP for OSA. The patients with a CPAP prescription will be followed up to determine their compliance with CPAP and data will be collected to determine the O2 saturation. Those patients with diagnosed obstructive sleep apnea without a CPAP prescription will also be followed to objectively determine the severity of OSA which would indicate whether they do not require CPAP owing to their mild OSA or they in fact may require CPAP due to change in weight etc. Preoperative overnight oximetry will be performed on all the OSA patients at home before surgery. In the postoperative period, all patients will be followed up with a nocturnal oximetry in the first two post-operative nights of hospital stay. Postoperative compliance to CPAP will be evaluated and recorded in all the patients. The patients' charts will be reviewed for any postoperative complications. The clinical management of patient will be left to the discretion of the perioperative care team.

Study Overview

Status

Completed

Conditions

Detailed Description

Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder. CPAP is established to be the first line treatment for OSA patients with improvement in quality of life and significant reduction in the incidence of cardiovascular events. However, the evidence on the efficacy of CPAP in the perioperative period is largely lacking. A prospective cohort study conducted by Brar et al. found that despite the use of prescibed CPAP therapy, 18% of OSA patients became hypoxic on the night following surgery and they advocated postoperative oximetry monitoring in CPAP treated OSA surgical patients.

The investigators would like to determine the effect of CPAP compliance in reducing postoperative hypoxia and other complications in the surgical patients with OSA. The results from this study would provide valuable data on the rate of non-compliance to CPAP in the surgical patients with a history of diagnosed OSA and a CPAP prescription and the impact of non-compliance to CPAP on postoperative outcomes, especially oxygen saturation.

In this study, all diagnosed OSA surgical patients with or without a CPAP prescription will be approached for informed consent to enroll in the study. All study participants will be monitored for O2 desaturation by using wrist-watch pulse oximeter at home for one night preoperatively and first 3 nights post-operatively at the hospital.

The subjects enrolled will bring their own CPAP units (certified by the hospital engineering department as per hospital policy) and mask to the hospital. The OSA patients without a CPAP prescription will be followed up perioperatively to determine the severity of their OSA and to ascertain the rationale of no CPAP prescription.

Pre and post-operative CPAP usage data will be collected through interviewing the patient, chart review and monitoring recording in the smart CPAP device.

Study Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult surgical patients (>18 yr) with a diagnosis of OSA with or without a CPAP prescription.

Scheduled for a non-cardiac surgery (general surgery, orthopedics, urology, plastic surgery and spine) that is expected to require a postoperative hospital stay of more than one night.

Description

Inclusion Criteria:

  1. All adult surgical patients (>18 yr) with a diagnosis of OSA with or without a CPAP prescription.
  2. Scheduled for a non-cardiac surgery (general surgery, orthopedics, urology, plastic surgery and spine) that is expected to require a postoperative hospital stay of more than one night.

Exclusion Criteria:

  1. They are unwilling or unable to give informed consent to the study.
  2. They are on supplemental oxygen preoperatively (daytime or nocturnal).
  3. They are pregnant.
  4. Surgery included tonsillectomy, septoplasty, uvuloplasty, pharyngoplasty, tracheostomy, or prolonged (> 48 hrs) postoperative mechanical ventilation of the lungs is anticipated. These procedures/interventions are likely to cure or at least modify the severity of OSA.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CPAP prescription group
Patients with a CPAP prescription (both compliant and noncompliant)
Without a CPAP prescription
Patients without a CPAP prescription to satisfy our primary goals/objectives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPAP compliance
Time Frame: (average CPAP use ≥ 4hrs / night).
CPAP compliance (average CPAP use ≥ 4hrs / night)
(average CPAP use ≥ 4hrs / night).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version date: October 6, 2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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