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CompletedNCT01650974HFNOTUpdated Apr 19, 2019

High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy

An interventional study of HFNOT in Hypoxia, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-04-19.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen therapy during diagnostic bronchoscopy.

Read the detailed description

Hypoxemia is frequently seen during diagnostic bronchoscopy. Nasal prong or other existing oxygen supply methods are often difficult to maintain adequate oxygenation during bronchoscopy. In particular, bronchoscopy to patients already showing hypoxemia can be dangerous even though applying conventional oxygen therapy. Thus, we want to elucidate the usefulness of nasal high flow oxygen therapy to hypoxemic patients undergoing diagnostic bronchoscopy.

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Conditions studied

  • Hypoxia

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Keywords

  • high flow nasal oxygen therapy
  • diagnostic bronchoscopy
03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 242 are open to participants now.

This study's enrollment of 136 is above the median of 45 across 854 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

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

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Who can participate

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

Eligibility criteria

Inclusion Criteria: 1 or 2

  1. PaO2 \< 60 mmHg on ABGA or SpO2 \< 90 % in room air AND SpO2 ≥ 95% or PaO2 ≥ 75mmHg in low flow oxygen therapy
  2. Planning to diagnostic bronchoscopic procedure (e.g. bronchial washing, BAL, bronchoscopic biopsy, EBUS-TBNA etc.)

Exclusion Criteria:

  1. patients who did not agree to provide information
  2. patients requiring for emergent intubation
  3. patients can not wear or be already applied high flow nasal oxygen therapy
  4. patients with unstable vital sign(e.g. severe hypotension, uncontrolled arrhythmia, etc.)
  5. patients with multiple organ failures
  6. patients with plan to therapeutic bronchoscopic procedure(e.g. intervention)
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
136 participants (actual)

Study arms

  • No intervention
    conventional oxygen therapy

    conventional nasal prong with FiO2 \~0.4

  • Experimental
    HFNOT

    high flow nasal oxygen therapy with starting FiO2 0.4 and Flow 40 L/min

    Device: HFNOT

  • Sham comparator
    sham-HFNOT

    same device with FiO2 \~0.4, NO high flow

    Device: HFNOT

Interventions

  • DeviceHFNOT

    high flow nasal oxygen therapy

    Also known as: high flow nasal oxygen therapy(OPTIFLOW)

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What researchers measure

Primary outcomes

  1. Success rate of bronchoscopy

    Success is defined as completion of planned diagnostic procedure with the oxygen saturation or partial pressure of oxygen in arterial blood was similar to the level of before the procedure. Failure is defined as incompletion of planned diagnostic procedure due to sustained hypoxemia or else. Furthermore failure is defined as hypoxemia(SaO2 \<88%) was developed more than 2 times even though planned procedure was completed.

    Time frame: 1 day

  2. Total duration of hypoxia

    total duration of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.

    Time frame: 1 day

Secondary outcomes

  1. frequency of hypoxia

    frequency of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.

    Time frame: 1 day

  2. switch to oxygen therapy method

    Increase oxygen apply or change of oxygen therapy method to high flow system.

    Time frame: 1 day

  3. change of respiratory symptoms

    scoring of dyspnea symptoms, patients comfort.

    Time frame: 1 day

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Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi-do 463-707, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01650974
Lead sponsor
Seoul National University Hospital
Responsible party
Young-Jae Cho (Seoul National University Bundang Hospital, Seoul National University Bundang Hospital) — Principal investigator
First posted
Jul 26, 2012
Start date
Jul 2012
Primary completion
Nov 2017
Completion
Nov 2017
Last update
Apr 19, 2019

Study contacts

Young-Jae Cho, MD, MPH
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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