Nasal High Flow Therapy in Surgical Patients with Unrecognized Obstructive Sleep Apnea

NCT ID: NCT03964376

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2025-01-08

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.

Conditions

Obstructive Sleep Apnea; Sleep Disordered Breathing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Nasal High Flow Group

Nasal High-Flow oxygen delivery will be applied starting at airflow of minimum 20 Litre/minute. It will be titrated in 15Litre/minute increments to 35 Litre/minute and a maximum 50 Litre/minute as determined by patient comfort. O2 supplementation will be managed by the anesthesia and surgical health care team to maintain the oxygen saturation level in the blood between 92-95%. In the Nasal High-Flow group, when SPO2 is in the range of 92-95%, air will be given instead of oxygen for the 1st 3 nights and during the day, if required, till discharge, whichever is earlier.

Group Type: EXPERIMENTAL

Nasal High Flow

Intervention Type: OTHER

Delivery of oxygen via OptiflowTM system (AirvoTM, Fisher \& Paykel Inc.) with airflow of 20 to 50 Litre/minute

Usual Care Group

In the usual care, patients will receive oxygen at 2-4 Litre/minute via nasal cannula or 6 Litre/minute via facemask titrated to keep SpO2 level in the range of 92-95%. When SpO2 level reaches in the range of 92-95%, oxygen delivery will be discontinued.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Delivery of oxygen at 2-4 Litre/minute via nasal cannula or 6 Litre/minute via face mask

Interventions

Nasal High Flow

Delivery of oxygen via OptiflowTM system (AirvoTM, Fisher \& Paykel Inc.) with airflow of 20 to 50 Litre/minute

Intervention Type: OTHER

Usual Care

Delivery of oxygen at 2-4 Litre/minute via nasal cannula or 6 Litre/minute via face mask

Intervention Type: OTHER

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).

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frances Chung, MBBS FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Toronto/ University Health Network

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Toronto Western Hopsital, Dept. of Anesthesia

Toronto, Ontario, Canada

Prince of Wales Hospital

Hong Kong, , Hong Kong

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Khoo Teck Puat Hospital

Singapore, , Singapore

Singapore General Hospital

Singapore, , Singapore

Countries

Canada; Hong Kong; Malaysia; Singapore

Other Identifiers

18-5980

Identifier Type: -

Identifier Source: org_study_id