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

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

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

Study Overview

• Status: Completed
• Conditions: Hypoxia
• Intervention / Treatment: Device: HFNOT

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; high flow nasal oxygen therapy; Other Names: high flow nasal oxygen therapy(OPTIFLOW)
SHAM_COMPARATOR: sham-HFNOT; same device with FiO2 ~0.4, NO high flow	Device: HFNOT; high flow nasal oxygen therapy; Other Names: high flow nasal oxygen therapy(OPTIFLOW)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Total duration of hypoxia	total duration of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Young-Jae Cho, MD, MPH, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): November 1, 2017
• Study Completion (ACTUAL): November 1, 2017

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (ESTIMATE): July 26, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: high flow nasal oxygen therapy; diagnostic bronchoscopy
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: E-1205-154-002; H-1206-074-414 (OTHER: Seoul National University Hospital)