NCT05075668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
Last Updated

October 13, 2021

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

November 13, 2019

Last Update Submit

September 29, 2021

Conditions

OSA

Keywords

CPAP therapyHigh flow nasal cannula

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    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

    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.

    10 hours (between 10pm on first postoperative night and 8am the following day)

Study Arms (4)

OSA support via CPAP face mask

ACTIVE COMPARATOR

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

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

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

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

Device: High flow nasal cannula (HFNC)

Interventions

CPAP face maskDEVICE

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

OSA support via CPAP face mask
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

Also known as: Optiflow™ High Flow therapy; Fisher and Paykel
OSA support via HFNC at 20 L/minOSA support via HFNC at 30 L/minOSA support via HFNC at 40 L/min

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (6)

  • 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.

    PMID: 23845744BACKGROUND

  • 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.

    PMID: 27698207BACKGROUND

  • 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.

    PMID: 17363769BACKGROUND

  • 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.

    PMID: 19952061BACKGROUND

  • 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.

    PMID: 25015548BACKGROUND

  • 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.

    PMID: 25957615BACKGROUND

Study Officials

  • Fung Chen Tsai, MMED (Anaes)

    Changi General Hospital, SingHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Department of Anaesthesia & Surgical Intensive Care

Study Record Dates

First Submitted

November 13, 2019

First Posted

October 13, 2021

Study Start

September 13, 2018

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

October 13, 2021

Record last verified: 2021-09

Locations

SG(1)