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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changi General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings