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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
July 24, 2012
July 26, 2012
March 3, 2017
July 2012
June 2017   (Final data collection date for primary outcome measure)
  • 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.
SpO2/FiO2 [ Time Frame: 1 day ]
SpO2/FiO2 will be measured during bronchoscopy
Complete list of historical versions of study NCT01650974 on ClinicalTrials.gov Archive Site
  • 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.
success rate of bronchoscopy [ Time Frame: 1 day ]
success rate of bronchoscopy will be recorded
Not Provided
Not Provided
 
High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Hypoxia
Device: HFNOT
high flow nasal oxygen therapy
Other Name: high flow nasal oxygen therapy(OPTIFLOW)
  • 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
    Intervention: Device: HFNOT
  • Sham Comparator: sham-HFNOT
    same device with FiO2 ~0.4, NO high flow
    Intervention: Device: HFNOT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
152
June 2017
June 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact: Young-Jae Cho, MD 82-10-9925-7058 lungdrcho@snubh.org
Contact: Jisoo Park, MD 82-10-6533-0452 subac1@naver.com
Korea, Republic of
 
 
NCT01650974
E-1205-154-002
H-1206-074-414 ( Other Identifier: Seoul National University Hospital )
Yes
Not Provided
Not Provided
Young-Jae Cho, Seoul National University Bundang Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Young-Jae Cho, MD, MPH Seoul National University Bundang Hospital
Seoul National University Hospital
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP