ClinicalTrials.gg
CompletedNCT03892408Updated Jun 13, 2024

High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial

An interventional study of Optiflow ™ in Foreign Bodies, Tumor and Stenosis Trachea, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by Yonsei University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on apnea in patients undergoing general anesthesia with rigid bronchoscopy compared with standard anesthesia methods.

02

Conditions studied

  • Foreign Bodies
  • Tumor
  • Stenosis Trachea
  • Bronchus Tumour
03

In context

Foreign Bodies

29 studies on the registry are indexed under Foreign Bodies; 8 are open to participants now.

Browse Foreign Bodies studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Patients undergoing general anesthesia with stent placement or bougination, or removal of a foreign body or a mass through a rigid bronchoscope
    1. Patients aged 19 or older who meet (ASA) physical class 2-4

Exclusion criteria

Exclusion Criteria:

    1. Patients with dementia or cognitive impairment
    1. pregnant women
    1. Patients undergoing extracorporeal membrane oxygenation (ECMO)
    1. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
    1. Patients with current maxillofacial trauma or basal skull fracture
    1. Patients who had previously undergone rigid bronchoscopy / surgery
    1. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Optiflow

    100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand)

    Device: Optiflow ™

  • No intervention
    Standard

    standard anesthesia

Interventions

  • DeviceOptiflow ™

    supply of 100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) plus standard oxygen supply through rigid bronchoscope during apnea period.

06

What researchers measure

Primary outcomes

  1. the lowest oxygen saturation

    the lowest value of oxygen saturation measured percutaneously at extremity.

    Time frame: apnea period during the rigidbroscopic procedure/surgery

Secondary outcomes

  1. Hypoxia occurs the first time

    Time frame: intraoperative (The time taken to reach the point at which peripheral oxygen saturation fell below 90 for the first time immediately after the onset of apnea)

  2. End-tidal carbon dioxide partial pressure

    Time frame: Intraoperative (end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea)

  3. Arterial oxygen / carbon dioxide partial pressure

    Time frame: shortly before start of apnea (within 30 seconds)

  4. Arterial oxygen / carbon dioxide partial pressure

    Time frame: shortly after end of apnea (within 30 seconds)

  5. hypoxemia related surgical interruptions

    Time frame: 4) hypoxemia related surgical interruptions during apneic period

07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine
    Seoul, 120-752, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2019 to primary completion in Aug 2022, 39 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2019
First posted
Mar 27, 2019
StartActual
Apr 21, 2019
Primary completionActual
Aug 19, 2022
CompletionActual
Aug 19, 2022
Last update
Jun 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03892408
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Mar 27, 2019
Start date
Apr 21, 2019
Primary completion
Aug 19, 2022
Completion
Aug 19, 2022
Last update
Jun 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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