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Completed

NCT Number: NCT05075668

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

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.

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Key information

Conditions

OSA

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore, 529889

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

CPAP face mask

Device

Two types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates

High flow nasal cannula (HFNC)

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 13, 2021
Registry last updated
Oct 13, 2021

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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