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

Hypoxia Clinical Trial

— HFNOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650974
• Other study ID #: E-1205-154-002
• Secondary ID: H-1206-074-414
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: November 2017

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypoxia

Intervention

Device:
• HFNOT
high flow nasal oxygen therapy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Primary	Total duration of hypoxia	total duration of hypoxia(oxygen saturation =88%) during procedure or after procedure.	1 day
Secondary	frequency of hypoxia	frequency of hypoxia(oxygen saturation =88%) during procedure or after procedure.	1 day
Secondary	switch to oxygen therapy method	Increase oxygen apply or change of oxygen therapy method to high flow system.	1 day
Secondary	change of respiratory symptoms	scoring of dyspnea symptoms, patients comfort.	1 day