Clinical trial NCT03964376: Nasal High Flow Therapy in Surgical Patients with Unrecognized Obstructive Sleep Apnea
Official title: Nasal High Flow Therapy Versus Postoperative Usual Care in Surgical Patients with Unrecognized Obstructive Sleep Apnea: a Randomized Controlled Trial (A PHASE 2 STUDY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Sleep Disordered Breathing
Keywords: Sleep Apnea
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 22
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study the investigators will determine whether using high flow oxygen in moderate-to-severe Obstructive Sleep Apnea patients following a major non cardiac surgery is more efficacious than usual care in preventing decrease in oxygen level in blood.

Detailed description: The POSA-II trial is a culmination of the investigator's program of research to prevent postoperative adverse outcomes in surgical patients with untreated Obstructive Sleep Apnea (OSA). It is a multi center open label, randomized clinical trial of nasal high-flow vs. usual care in patients with untreated moderate-to-severe OSA undergoing major non cardiac surgery. It is a proof of concept trial to show that nasal high-flow reduces severe desaturation, the causal mechanism for OSA-related adverse events, and to collect key feasibility data for a large international multi center trial with enough power to detect effects on the clinical outcomes. Eligible patients undergoing major non cardiac surgery with high-risk OSA will have a home sleep study. One hundred and ninety patients with moderate-to-severe Sleep Apnea will be randomized into either nasal high-flow or usual care group. Sleep studies, oximetry, electrocardiogram (ECG), and Troponin will be done preoperatively. Postoperatively, ECG and Troponin will be determined daily for the 1st three days, and nocturnal oximetry for the 1st 3 nights. Patients will be followed during their hospitalization and for 30 days postoperatively to ascertain any adverse outcomes. A blinded clinical events committee will adjudicate all components of the composite outcome.

Eligibility criteria: Inclusion Criteria:

* Adult, age ≥45 years, undergoing major elective non cardiac surgery under general and/or regional anesthesia with anticipated overnight stay or longer in hospital
* Patients with untreated moderate-to-severe Obstructive Sleep Apnea.
* STOP-Bang score 5 or higher

Exclusion Criteria:

* Predetermined need for postoperative CPAP therapy or ventilation,
* Cheyne-Stokes respiration or Central Apnea,
* Oxygen dependent due to moderate to severe chronic obstructive lung disease available Forced Expiratory Volume at 1 second of \< 50% predicted) or advanced interstitial lung disease,
* Pre-existing chronic hypercapnia or obesity hypoventilation syndrome, Intracranial and otolaryngological procedures, and
* Unable to use nasal high-flow (nasal/oral malformations, pre-existing tracheostomy, planned postoperative nasal packing).

Primary outcomes:
measure: Oxygen Desaturation Index (ODI)
timeFrame: 72 hours
Secondary outcomes:
measure: Time (minutes) spent below 90% and 80% SpO2 (T90, T80)
timeFrame: 72 hours
measure: Compliance to Nasal High-Flow
timeFrame: 72 hours
measure: Titration protocol of nasal high-flow
timeFrame: 72 hours
measure: The rate of postoperative adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hopsital, Dept. of Anesthesia
state: Ontario
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: University of Toronto/ University Health Network
name: Frances Chung, MBBS FRCPC
role: PRINCIPAL_INVESTIGATOR
References: