NCT03964376

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

Nasal High Flow Therapy Versus Postoperative Usual Care in Surgical Patients with Unrecognized Obstructive Sleep Apnea: a Randomized Controlled Trial (A PHASE 2 STUDY)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Nasal High Flow	Delivery of oxygen via OptiflowTM system (AirvoTM, Fisher \& Paykel Inc.) with airflow of 20 to 50 Litre/minute
OTHER	Usual Care	Delivery of oxygen at 2-4 Litre/minute via nasal cannula or 6 Litre/minute via face mask

Timeline

• Start date: 2019-10-01
• Primary completion: 2025-01-08
• Completion: 2025-01-08
• First posted: 2019-05-28
• Last updated: 2025-01-13

Locations

8 sites across 4 countries: Canada, Hong Kong, Malaysia, Singapore