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High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892408
Recruitment Status : Unknown
Verified March 2019 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : March 27, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:
The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on apnea in patients undergoing general anesthesia with rigid bronchoscopy compared with standard anesthesia methods.

Condition or disease Intervention/treatment Phase
Foreign Bodies Tumor Stenosis Trachea Bronchus Tumour Device: Optiflow ™ Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective Randomized, open label Trial
Masking: None (Open Label)
Masking Description: triple (Participant, Care Provider, investigator)
Primary Purpose: Prevention
Official Title: High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial
Actual Study Start Date : March 21, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Optiflow
100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand)
 Device: Optiflow ™
supply of 100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) plus standard oxygen supply through rigid bronchoscope during apnea period.
No Intervention: Standard
standard anesthesia


Outcome Measures
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Primary Outcome Measures :
  1. the lowest oxygen saturation [ Time Frame: apnea period during the rigidbroscopic procedure/surgery ]
    the lowest value of oxygen saturation measured percutaneously at extremity.


Secondary Outcome Measures :
  1. Hypoxia occurs the first time [ Time Frame: intraoperative (The time taken to reach the point at which peripheral oxygen saturation fell below 90 for the first time immediately after the onset of apnea) ]
  2. End-tidal carbon dioxide partial pressure [ Time Frame: Intraoperative (end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea) ]
  3. Arterial oxygen / carbon dioxide partial pressure [ Time Frame: shortly before start of apnea (within 30 seconds) ]
  4. Arterial oxygen / carbon dioxide partial pressure [ Time Frame: shortly after end of apnea (within 30 seconds) ]

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

Inclusion Criteria:

  • 1. Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope
  • 2. Patients aged 19 or older who meet American Society of Anesthesiologists (ASA) physical class 2-4

Exclusion Criteria:

  • 1. Patients with dementia or cognitive impairment
  • 2. pregnant women
  • 3. Patients undergoing extracorporeal membrane oxygenation (ECMO)
  • 4. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
  • 5. Patients with current maxillofacial trauma or basal skull fracture
  • 6. Patients who had previously undergone rigid bronchoscopy / surgery
  • 7. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
Contacts and Locations
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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): NCT03892408


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Young Jun Oh, M.D., PhD.    82-2-2224-4428    yjoh@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03892408    
Other Study ID Numbers: 1-2019-0005
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Foreign Bodies
Wounds and Injuries