Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Association of CPAP Compliance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02796846
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Frances Chung, University Health Network, Toronto

Tracking Information
First Submitted Date June 7, 2016
First Posted Date June 13, 2016
Last Update Posted Date July 8, 2019
Study Start Date June 2015
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2016)
CPAP compliance [ Time Frame: (average CPAP use ≥ 4hrs / night). ]
CPAP compliance (average CPAP use ≥ 4hrs / night)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Association of CPAP Compliance Study
Official Title The Association of CPAP Compliance and Nocturnal Hypoxemia in the Perioperative Period
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Obstructive Sleep Apnea
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 15, 2017)
158
Original Estimated Enrollment
 (submitted: June 10, 2016)
108
Actual Study Completion Date July 2019
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02796846
Other Study ID Numbers Version date: October 6, 2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. Frances Chung, University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Not Provided
Investigators Not Provided
PRS Account University Health Network, Toronto
Verification Date July 2019