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Nasal High Flow Oxygen Therapy in Hypoxemic Patients Undergoing Diagnostic Bronchoscopy: (HFNOT)

This study is currently recruiting participants.
Verified July 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Young-Jae Cho, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01650974
First received: July 24, 2012
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention
Hypoxemia
 Device: nasal high flow oxygen therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Nasal High Flow Oxygen Therapy vs. Conventional Oxygen Supplementation in Hypoxemic Patients Undergoing Diagnostic Bronchoscopy: A Prospective, Randomized, Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • SpO2/FiO2 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    SpO2/FiO2 will be measured during bronchoscopy


Secondary Outcome Measures:
  • success rate of bronchoscopy [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    success rate of bronchoscopy will be recorded


Estimated Enrollment: 38
Study Start Date: July 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nasal high flow oxygen therapy
nasal high flow oxygen therapy with starting FiO2 0.4 and Flow 40 L/min
 Device: nasal high flow oxygen therapy
nasal high flow oxygen therapy
Other Name: nasal high flow 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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: [1 OR 2] AND 3

  1. FEV1< 60 % and/or mMRC scale >= 2
  2. PaO2 < 60 mmHg on ABGA or SpO2 < 88 % in room air
  3. PaO2/FiO2 ratio >= 150mmHg

Exclusion Criteria:

  1. patients who did not agree to provide information
  2. patients has multiple organ failures, immunosuppressive state
  3. patients can not wear or be already applied nasal high flow oxygen therapy
  4. patients requiring for emergent intubation
  5. patients with respiratory failure caused by neurologic disease
  6. pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650974

Contacts
Contact: Young-Jae Cho 82-10-9925-7058 lungdrcho@snubh.org
Contact: Kyoung Hee Kim 82-10-9430-1127 heeyarobi@hanmail.net

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: Kyoung Hee Kim     82-10-9430-1127     heeyarobi@hanmail.net    
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

No publications provided

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
Study First Received: July 24, 2012
Last Updated: July 25, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
nasal high flow oxygen therapy
diagnostic bronchoscopy

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

ClinicalTrials.gov processed this record on May 16, 2013