OSANCT05075668
Efficacy of HFNC as an Alternative to CPAP Therapy in Surgical Patients With Suspected Moderate to Severe OSA
A study testing CPAP face mask and High flow nasal cannula (HFNC) in people with OSA, run by Changi General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- OSA
- What is being tested?
- CPAP face mask and High flow nasal cannula (HFNC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Sep 2018to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- OSA
- Being tested
- CPAP face mask, High flow nasal cannula (HFNC)
- Keywords
- CPAP therapy, High flow nasal cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP face maskDevice
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
Also called Optiflow™ High Flow therapy; Fisher and Paykel
Two types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates
| Study group | Role | What they receive |
|---|---|---|
| OSA support via CPAP face mask | Active comparator | Auto-titrated according to the settings made by sleep physicians, FiO2 0.21 Receives: Device: CPAP face mask |
| OSA support via HFNC at 20 L/min | Active comparator | High flow nasal insufflation of air (FiO2 0.21) at 20 L/min Receives: Device: High flow nasal cannula (HFNC) |
| OSA support via HFNC at 30 L/min | Active comparator | High flow nasal insufflation of air (FiO2 0.21) at 30 L/min Receives: Device: High flow nasal cannula (HFNC) |
| OSA support via HFNC at 40 L/min | Active comparator | High flow nasal insufflation of air (FiO2 0.21) at 40 L/min Receives: Device: High flow nasal cannula (HFNC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with documented desaturations (defined as >4% drop from baseline)
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
Measured: 10 hours (between 10pm on first postoperative night and 8am the following day)
Secondary outcomes (3)
Number of participants who need for supplemental oxygen and/ or the need for other interventions to reverse the desaturations.
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
Measured: 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
The patients' perceptions of the comfort of CPAP face mask and/ or high flow nasal insufflation
Measured: 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.
OSA patients who receive CPAP face mask or high flow nasal insufflation on the first
Measured: 10 hours (between 10pm on first postoperative night and 8am the following day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start13 Sep 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsai Fung Chen, Changi General Hospital
- Investigators
- Fung Chen Tsai, MMED (Anaes), Principal investigator, Changi General Hospital, SingHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075668
- Sponsor's protocol ID
- 2018/2142
- Status last verified
- Sep 2021
- First submitted
- 13 Nov 2019
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23845744Zhang 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.
PubMed 27698207McGinley 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.
PubMed 17363769Nilius 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.
PubMed 19952061Sowho 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.
PubMed 25015548Nilius 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.
PubMed 25957615
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05075668
- Acronym / sponsor ID
- 2018/2142
- Conditions
- OSA
- Keywords
- CPAP therapy, High flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OSA support via CPAP face mask | Active comparator | Device: CPAP face maskAuto-titrated according to the settings made by sleep physicians, FiO2 0.21 |
| OSA support via HFNC at 20 L/min | Active comparator | Device: High flow nasal cannula (HFNC)High flow nasal insufflation of air (FiO2 0.21) at 20 L/min |
| OSA support via HFNC at 30 L/min | Active comparator | Device: High flow nasal cannula (HFNC)High flow nasal insufflation of air (FiO2 0.21) at 30 L/min |
| OSA support via HFNC at 40 L/min | Active comparator | Device: High flow nasal cannula (HFNC)High flow nasal insufflation of air (FiO2 0.21) at 40 L/min |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP face maskTwo types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates | Device | OSA support via CPAP face mask |
| High flow nasal cannula (HFNC)Also: Optiflow™ High Flow therapy; Fisher and PaykelTwo types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates | Device | OSA support via HFNC at 20 L/min, OSA support via HFNC at 30 L/min, OSA support via HFNC at 40 L/min |
Primary outcome
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
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Background: PubMed 23845744Gotera 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.
- Background: PubMed 27698207Zhang 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.
- Background: PubMed 17363769McGinley 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.
- Background: PubMed 19952061Nilius 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.
- Background: PubMed 25015548Sowho 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.
- Background: PubMed 25957615Nilius 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fung Chen Tsai, MMED (Anaes) principal investigator
Changi General Hospital, SingHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP face mask and High flow nasal cannula (HFNC) in people with OSA, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05075668, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.