Efficacy of HFNC as an Alternative to CPAP Therapy in Surgical Patients With Suspected Moderate to Severe OSA

September 29, 2021 updated by: Tsai Fung Chen, Changi General Hospital

Continuous Positive Airway Pressure Therapy Via Conventional CPAP Face Mask Versus High Flow Nasal Cannula in OSA Patients on the First Postoperative Night- a Pilot Randomised Study

High flow, humidified, temperature-regulated nasal insufflation is not a new concept. It is used widely in the treatment of hypoxaemic respiratory failure in critically ill patients, as an alternative to non-invasive positive ventilation via face or nasal mask. Recently, its use has been extended to the perioperative setting for pre-oxygenation and prolonging apnoeic time to desaturation. Both CPAP and high flow nasal cannula insufflation devices are licensed for use clinically in Singapore. We conduct this pilot study because its perioperative use in our adult OSA population is currently not well-defined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Continuous positive airway pressure (CPAP) therapy is the only treatment for obstructive sleep apnoea (OSA) shown to reduce its long-term adverse effects on the cardiovascular system. However, due to difficult patient-mask interface and discomfort, compliance rate amongst patients with OSA is low, and reported to be only between 20-50%. High flow, humidified, temperature-regulated nasal cannula insufflation (of air or oxygen) is a well-documented and safe treatment in intensive care, paediatrics and respiratory medicine for patients with hypoxaemic respiratory failure. Its use in adult patients with obstructive sleep apnoea, especially in the perioperative setting is not well studied. Our hospital has a ''fast-track'' protocol for OSA patients who require surgery. They are started on CPAP therapy 2 to 5 days prior to surgery and in the immediate post operative period (ie. perioperatively). If these patients are non-compliant to the CPAP mask device, high flow nasal insufflation is a possible alternative treatment. We aim to randomise these patients into 4 groups, receiving conventional CPAP face mask or high flow nasal cannula at 3 flow rates, and study them with respect to incidence and number of documented desaturations. In addition, patient satisfaction, compliance to device and any adverse events will be monitored.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 21-85 years old presenting for elective surgery.
  • Suspected/possible OSA patients who are enrolled in the "fast-track OSA protocol" in the pre-assessment clinic
  • Patients started on CPAP therapy at least one day pre-operatively
  • Patients who are admitted to the High Dependency unit for postoperative monitoring.

Exclusion Criteria:

  • Patients with nasal obstruction.
  • Patients undergoing nasal or facial surgery, or surgery to treat OSA (eg. uvulopalatopharyngoplasty).
  • Patients who already require a higher oxygen concentration (FiO2 > 0.21) preoperatively.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OSA support via CPAP face mask
Auto-titrated according to the settings made by sleep physicians, FiO2 0.21
Device: CPAP face mask
Two types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates
Active Comparator: OSA support via HFNC at 20 L/min
High flow nasal insufflation of air (FiO2 0.21) at 20 L/min
Device: High flow nasal cannula (HFNC)
Two types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates
Other Names:
  • Optiflow™ High Flow therapy; Fisher and Paykel
Active Comparator: OSA support via HFNC at 30 L/min
High flow nasal insufflation of air (FiO2 0.21) at 30 L/min
Device: High flow nasal cannula (HFNC)
Two types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates
Other Names:
  • Optiflow™ High Flow therapy; Fisher and Paykel
Active Comparator: OSA support via HFNC at 40 L/min
High flow nasal insufflation of air (FiO2 0.21) at 40 L/min
Device: High flow nasal cannula (HFNC)
Two types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates
Other Names:
  • Optiflow™ High Flow therapy; Fisher and Paykel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with documented desaturations (defined as >4% drop from baseline)
Time Frame: 10 hours (between 10pm on first postoperative night and 8am the following day)
Number of documented desaturations (defined as >4% below baseline) in OSA patients who receive CPAP face mask or high flow nasal insufflation on the first postoperative night
10 hours (between 10pm on first postoperative night and 8am the following day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who need for supplemental oxygen and/ or the need for other interventions to reverse the desaturations.
Time Frame: 10 hours (between 10pm on first postoperative night and 8am the following day)
Need for supplemental oxygen and/or the need for other interventions to reverse desaturations in OSA patients who receive CPAP face mask or high flow nasal insufflation on the first postoperative night
10 hours (between 10pm on first postoperative night and 8am the following day)
Patients' perceptions of the comfort of each device on scale of 0 to 100
Time Frame: 10 hours (between 10pm on first postoperative night and 8am the following day)
The patients' perceptions of the comfort of CPAP face mask and/ or high flow nasal insufflation
10 hours (between 10pm on first postoperative night and 8am the following day)
Number of participants with any adverse effects of the applied therapy in the immediate postoperative setting.
Time Frame: 10 hours (between 10pm on first postoperative night and 8am the following day)
OSA patients who receive CPAP face mask or high flow nasal insufflation on the first
10 hours (between 10pm on first postoperative night and 8am the following day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changi General Hospital

Investigators

  • Principal Investigator: Fung Chen Tsai, MMED (Anaes), Changi General Hospital, SingHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2018

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018/2142

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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