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

Primary Purpose

Hypoxia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HFNOT
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypoxia focused on measuring high flow nasal oxygen therapy, diagnostic bronchoscopy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Sham Comparator

Arm Label

conventional oxygen therapy

HFNOT

sham-HFNOT

Arm Description

conventional nasal prong with FiO2 ~0.4

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

same device with FiO2 ~0.4, NO high flow

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 24, 2012
Last Updated
April 17, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01650974
Brief Title
High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy
Acronym
HFNOT
Official Title
High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy: A Prospective, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
high flow nasal oxygen therapy, diagnostic bronchoscopy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional oxygen therapy
Arm Type
No Intervention
Arm Description
conventional nasal prong with FiO2 ~0.4
Arm Title
HFNOT
Arm Type
Experimental
Arm Description
high flow nasal oxygen therapy with starting FiO2 0.4 and Flow 40 L/min
Arm Title
sham-HFNOT
Arm Type
Sham Comparator
Arm Description
same device with FiO2 ~0.4, NO high flow
Intervention Type
Device
Intervention Name(s)
HFNOT
Other Intervention Name(s)
high flow nasal oxygen therapy(OPTIFLOW)
Intervention Description
high flow nasal oxygen therapy
Primary Outcome Measure Information:
Title
Success rate of bronchoscopy
Description
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
Title
Total duration of hypoxia
Description
total duration of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
frequency of hypoxia
Description
frequency of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.
Time Frame
1 day
Title
switch to oxygen therapy method
Description
Increase oxygen apply or change of oxygen therapy method to high flow system.
Time Frame
1 day
Title
change of respiratory symptoms
Description
scoring of dyspnea symptoms, patients comfort.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Jae Cho, MD, MPH
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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

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