Clinical trial NCT05075668: Efficacy of HFNC as an Alternative to CPAP Therapy in Surgical Patients With Suspected Moderate to Severe OSA
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Keywords: CPAP therapy
High flow nasal cannula
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with documented desaturations (defined as >4% drop from baseline)
timeFrame: 10 hours (between 10pm on first postoperative night and 8am the following day)
Secondary outcomes:
measure: Number of participants who need for supplemental oxygen and/ or the need for other interventions to reverse the desaturations.
timeFrame: 10 hours (between 10pm on first postoperative night and 8am the following day)
measure: Patients' perceptions of the comfort of each device on scale of 0 to 100
timeFrame: 10 hours (between 10pm on first postoperative night and 8am the following day)
measure: Number of participants with any adverse effects of the applied therapy in the immediate postoperative setting.
timeFrame: 10 hours (between 10pm on first postoperative night and 8am the following day)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital, SingHealth
name: Fung Chen Tsai, MMED (Anaes)
role: PRINCIPAL_INVESTIGATOR
References:
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