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The Association of CPAP Compliance Study

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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

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.

Condition or disease
Obstructive Sleep Apnea

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.


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Study Type : Observational
Actual Enrollment : 158 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Association of CPAP Compliance and Nocturnal Hypoxemia in the Perioperative Period
Study Start Date : June 2015
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.



Primary Outcome Measures :
  1. CPAP compliance [ Time Frame: (average CPAP use ≥ 4hrs / night). ]
    CPAP compliance (average CPAP use ≥ 4hrs / night)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796846


Locations
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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto

Publications:
Ramakant Sharma ISB. CPAP for Obstructive Sleep Apnea in the Post-Operative Setting: An Oximetry Evaluation Study. J Sleep Disord Ther 2013;02.

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Responsible Party: Dr. Frances Chung, Staff Anesthesiologist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02796846     History of Changes
Other Study ID Numbers: Version date: October 6, 2017
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Frances Chung, University Health Network, Toronto:
CPAP (continuous positive airway pressure)
OSA (Obstructive sleep apnea)

Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases