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

This study is currently recruiting participants.
Verified March 2017 by Young-Jae Cho, Seoul National University Bundang Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01650974
First Posted: July 26, 2012
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Young-Jae Cho, Seoul National University Bundang Hospital
  Purpose
The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen therapy during diagnostic bronchoscopy.

Condition Intervention
Hypoxia Device: HFNOT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy: A Prospective, Randomized, Controlled Study

Resource links provided by NLM:


Further study details as provided by Young-Jae Cho, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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.


  • Total duration of hypoxia [ Time Frame: 1 day ]
    total duration of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.


Secondary Outcome Measures:
  • frequency of hypoxia [ Time Frame: 1 day ]
    frequency of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.

  • switch to oxygen therapy method [ Time Frame: 1 day ]
    Increase oxygen apply or change of oxygen therapy method to high flow system.

  • change of respiratory symptoms [ Time Frame: 1 day ]
    scoring of dyspnea symptoms, patients comfort.


Estimated Enrollment: 152
Study Start Date: July 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: high flow nasal oxygen therapy(OPTIFLOW)

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.
  Eligibility

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650974


Contacts
Contact: Young-Jae Cho, MD 82-10-9925-7058 lungdrcho@snubh.org
Contact: Jisoo Park, MD 82-10-6533-0452 subac1@naver.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Young-Jae Cho    82-10-9925-7058    lungdrcho@snubh.org   
Contact: Youlim Kim    82-10-4447-7551    89503@snubh.org   
Principal Investigator: Young-Jae Cho, MD, MPH         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Young-Jae Cho, MD, MPH Seoul National University Bundang Hospital
  More Information

Responsible Party: Young-Jae Cho, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01650974     History of Changes
Other Study ID Numbers: E-1205-154-002
H-1206-074-414 ( Other Identifier: Seoul National University Hospital )
First Submitted: July 24, 2012
First Posted: July 26, 2012
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Young-Jae Cho, Seoul National University Bundang Hospital:
high flow nasal oxygen therapy
diagnostic bronchoscopy

Additional relevant MeSH terms:
Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms