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

Not Applicable

Completed

• Conditions: Hypoxia
• Interventions: Device: HFNOT

• Registration Number: NCT01650974
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-26
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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.)

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFNOT	HFNOT	high flow nasal oxygen therapy with starting FiO2 0.4 and Flow 40 L/min
sham-HFNOT	HFNOT	same device with FiO2 \~0.4, NO high flow

Primary Outcome Measures

Name	Time	Method
Success rate of bronchoscopy	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.
Total duration of hypoxia	1 day	total duration of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.

Secondary Outcome Measures

Name	Time	Method
frequency of hypoxia	1 day	frequency of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.
switch to oxygen therapy method	1 day	Increase oxygen apply or change of oxygen therapy method to high flow system.
change of respiratory symptoms	1 day	scoring of dyspnea symptoms, patients comfort.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of