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

NCT03964376 | Completed DMC

• 1 other identifier: 18-5980
• Study Type: interventional
• Target: 22
• Locations: 4 countries
• Sites: 8

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.

Conditions

Obstructive Sleep Apnea; Sleep Disordered Breathing

Keywords

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Oxygen Desaturation Index (ODI)

  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.

  72 hours

Secondary Outcomes (4)

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

  72 hours

• Compliance to Nasal High-Flow

  72 hours

• Titration protocol of nasal high-flow

  72 hours

• The rate of postoperative adverse events

  30 days

Study Arms (2)

Nasal High Flow Group

EXPERIMENTAL

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.

Other: Nasal High Flow

Usual Care Group

OTHER

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.

Other: Usual Care

Interventions

Nasal High Flow OTHER

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

Nasal High Flow Group

Usual Care OTHER

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

Usual Care Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (8)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Toronto Western Hopsital, Dept. of Anesthesia

Toronto, Ontario, M5T2S8, Canada

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Khoo Teck Puat Hospital

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Frances Chung, MBBS FRCPC

  University of Toronto/ University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: May 28, 2019
• Study Start: October 1, 2019
• Primary Completion: January 8, 2025
• Study Completion: January 8, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

MY (2); CA (3); SG (2); HK (1)