The Association of CPAP Compliance Study

NCT02796846 | Completed

• 1 other identifier: Version date: October 6, 2017
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

CPAP (continuous positive airway pressure); OSA (Obstructive sleep apnea)

Outcome Measures

Primary Outcomes (1)

• CPAP compliance

  CPAP compliance (average CPAP use ≥ 4hrs / night)

  (average CPAP use ≥ 4hrs / night).

Study Arms (2)

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.

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

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.

You may qualify if:

• 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.

You may not qualify if:

• They are unwilling or unable to give informed consent to the study.
• They are on supplemental oxygen preoperatively (daytime or nocturnal).
• They are pregnant.
• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

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  BACKGROUND

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  PMID: 33975540 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Microcephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 13, 2016
• Study Start: June 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)