Obstructive Sleep Apnea Airway Evaluation

NCT03361553 | Completed DMC

• 1 other identifier: 16-6160
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Current practice guidelines recommend obstructive sleep apnea (OSA) patients to stay in the post anesthetic care unit (PACU) until the risk of respiratory depression has subsided. Inevitably, a greater demand on hospital resource utilization in these patients will increase health care cost. Polysomnography (PSG) and screening questionnaires can identify OSA but they are limited by accessibility and false positive results, respectively. Inaccurate OSA identification misguides postoperative surveillance plan. In contrast with MRI and CT scans, ultrasound is more accessible and more likely a practical tool for OSA screening. However, before clinical application, airway ultrasound (US) exam must undergo vigorous testing to check its utility, accuracy, inter-observer reliability and its ability to identify OSA and its severity.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Correlation of airway parameter measurements with Apnea-Hypopnea Index (AHI) values on Polysomnography (PSG)

  The primary study outcome will be the discriminatory performance of each one of the airway parameters, against the OSA status (moderate/severe) as diagnosed by PSG.

  2 years

Secondary Outcomes (1)

• Feasibility of airway Ultrasound (US) examination;

  2 years

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

Suspected / Recently diagnosed untreated Obstructive Sleep Apnea (amendment authorized 20/12/2017) / Non-compliant to OSA treatment

You may qualify if:

• age≥18
• ASA physical status I - IV;
• Suspected to have OSA for clinical reasons such as high risk on screening questionnaire i.e., a STOP-Bang score \>3, and referred to have a sleep study for OSA diagnosis by the clinical team at any point of care during the perioperative period (such as the clinic using the screening tool, during or after surgery in the ward experiencing recurrent upper airway obstructive events, need for CPAP in the postoperative period and / or suspected to have obstructive airway events). Or;
• Patients who were recently diagnosed to have OSA and underwent a laboratory sleep study within the last year.
• Patients who were recently diagnosed to have OSA but are non-compliant with treatment. Compliance defined as: median nightly CPAP or APAP use \> 70% of the nights, and for longer than 4 hours of nightly use during the last 3 months),43 or using oral appliance use (use \> 70% of nights, and for longer than 4 hours of nightly use in the last 3 months.

You may not qualify if:

• failure to understand and provide consent
• past history of oral, head and neck surgery (e.g., OSA corrective surgery)
• active head \& neck disease (e.g., cancer, infection and radiotherapy);
• inability to perform breathing tests per instruction
• Patients currently on treatment for OSA (as this may interfere with the upper airway dimensions and the US assessment may not be accurate)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Hospital for Special Surgery, New York: collaborator

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, 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

Study Officials

• Mandeep Singh

  Department of Anesthesia, Toronto Western Hospital- UHN, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: December 5, 2017
• Study Start: July 20, 2017
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

CA (1)