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

NCT ID: NCT05075668

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-13

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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OSA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OSA support via CPAP face mask

Auto-titrated according to the settings made by sleep physicians, FiO2 0.21

Group Type ACTIVE_COMPARATOR

CPAP face mask

Intervention Type DEVICE

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

OSA support via HFNC at 20 L/min

High flow nasal insufflation of air (FiO2 0.21) at 20 L/min

Group Type ACTIVE_COMPARATOR

High flow nasal cannula (HFNC)

Intervention Type DEVICE

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

OSA support via HFNC at 30 L/min

High flow nasal insufflation of air (FiO2 0.21) at 30 L/min

Group Type ACTIVE_COMPARATOR

High flow nasal cannula (HFNC)

Intervention Type DEVICE

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

OSA support via HFNC at 40 L/min

High flow nasal insufflation of air (FiO2 0.21) at 40 L/min

Group Type ACTIVE_COMPARATOR

High flow nasal cannula (HFNC)

Intervention Type DEVICE

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

Interventions

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CPAP face mask

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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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Optiflowâ„¢ High Flow therapy; Fisher and Paykel

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tsai Fung Chen

Consultant, Department of Anaesthesia & Surgical Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fung Chen Tsai, MMED (Anaes)

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital, SingHealth

Locations

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Changi General Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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Gotera C, Diaz Lobato S, Pinto T, Winck JC. Clinical evidence on high flow oxygen therapy and active humidification in adults. Rev Port Pneumol. 2013 Sep-Oct;19(5):217-27. doi: 10.1016/j.rppneu.2013.03.005. Epub 2013 Jul 8.

Reference Type BACKGROUND
PMID: 23845744 (View on PubMed)

Zhang J, Lin L, Pan K, Zhou J, Huang X. High-flow nasal cannula therapy for adult patients. J Int Med Res. 2016 Dec;44(6):1200-1211. doi: 10.1177/0300060516664621. Epub 2016 Oct 3.

Reference Type BACKGROUND
PMID: 27698207 (View on PubMed)

McGinley BM, Patil SP, Kirkness JP, Smith PL, Schwartz AR, Schneider H. A nasal cannula can be used to treat obstructive sleep apnea. Am J Respir Crit Care Med. 2007 Jul 15;176(2):194-200. doi: 10.1164/rccm.200609-1336OC. Epub 2007 Mar 15.

Reference Type BACKGROUND
PMID: 17363769 (View on PubMed)

Nilius G, Wessendorf T, Maurer J, Stoohs R, Patil SP, Schubert N, Schneider H. Predictors for treating obstructive sleep apnea with an open nasal cannula system (transnasal insufflation). Chest. 2010 Mar;137(3):521-8. doi: 10.1378/chest.09-0357. Epub 2009 Dec 1.

Reference Type BACKGROUND
PMID: 19952061 (View on PubMed)

Sowho MO, Woods MJ, Biselli P, McGinley BM, Buenaver LF, Kirkness JP. Nasal insufflation treatment adherence in obstructive sleep apnea. Sleep Breath. 2015 Mar;19(1):351-7. doi: 10.1007/s11325-014-1027-4.

Reference Type BACKGROUND
PMID: 25015548 (View on PubMed)

Nilius G, Franke KJ, Domanski U, Schroeder M, Ruhle KH. Effect of APAP and heated humidification with a heated breathing tube on adherence, quality of life, and nasopharyngeal complaints. Sleep Breath. 2016 Mar;20(1):43-9. doi: 10.1007/s11325-015-1182-2. Epub 2015 May 10.

Reference Type BACKGROUND
PMID: 25957615 (View on PubMed)

Other Identifiers

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2018/2142

Identifier Type: -

Identifier Source: org_study_id