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NCT Number: NCT03964376

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disordered Breathing Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nasal High Flow

Other

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

Usual Care

Other

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

Primary outcomes

  1. Oxygen Desaturation Index (ODI)

    Time frame: 72 hours

    The investigators will measure Oxygen Desaturation Index(the number of desaturation events per hour) by using Pulsox 300i for maximum of three nights post-operatively at the hospital preventing the severe desaturation in surgical patients with untreated moderate-to-severe OSA undergoing major non cardiac surgery. Higher values of ODI are considered worst. If successful, it will provide feasibility data for the performance of a large randomized clinical trial focusing on clinical outcomes and the cost effectiveness of the therapy to the health care system.

Secondary outcomes

  1. Time (minutes) spent below 90% and 80% SpO2 (T90, T80)

    Time frame: 72 hours

    The investigators will measure the time spent in minutes with SpO2 between 0% to %79 (T80) and the time spent in minutes with SpO2 between 0% to 89% (T90). ODI, T90 and T80 will serve as surrogate outcomes of adverse events in the pilot study. In POSA study, an increase in time spent with SpO2 <80% after surgery was associated with a higher risk of postoperative vascular events under usual care.

  2. Compliance to Nasal High-Flow

    Time frame: 72 hours

    To determine the tolerability and adherence of patients with OSA to Nasal High-Flow in the wards using a 10-point numeric rating scale to grade general discomfort, in which points 0 to 3 means not comfortable, 4 to 6 means comfortable and 7 to 10 means the most comfortable.

  3. Titration protocol of nasal high-flow

    Time frame: 72 hours

    The appropriate titration protocol of nasal high-flow will be measured; FiO2: flow rates.

  4. The rate of postoperative adverse events

    Time frame: 30 days

    The rate of postoperative cardiovascular events will be collected during hospitalization and following discharge from hospital, emergency department (if visited) and physician records, and patient by phone at day 30. Adjudicators who are blinded to the results of the ECG, Troponin, sleep study and oximetry will evaluate outcome events.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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)

Acronym: POSAII

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 28, 2019
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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