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Completed

NCT Number: NCT01650974

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1 or 2

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

Exclusion criteria

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

Treatment and study plan

HFNOT

Device

high flow nasal oxygen therapy

Other names: high flow nasal oxygen therapy(OPTIFLOW)

Primary outcomes

  1. Success rate of bronchoscopy

    Time frame: 1 day

    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.

  2. Total duration of hypoxia

    Time frame: 1 day

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

Secondary outcomes

  1. frequency of hypoxia

    Time frame: 1 day

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

  2. switch to oxygen therapy method

    Time frame: 1 day

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

  3. change of respiratory symptoms

    Time frame: 1 day

    scoring of dyspnea symptoms, patients comfort.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy: A Prospective, Randomized, Controlled Study

Acronym: HFNOT

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jul 26, 2012
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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