The Utility of Oxygen Insufflation During Flexible Fiberoptic Bronchoscope-guided Intubation

July 8, 2019 updated by: Yonsei University

This study investigate the utility of continuous oxygen insufflation during fiberoptic bronchoscope-guided intubation.

One group receives oxygen via suction channel of fiberoptic bronchoscope during intubation.

The other group does not receive oxygen during fiberoptic bronchoscope-guided intubation.

Then, the velocity of deoxygenation difference of PaO2(baseline

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fiberoptic bronchoscope-guided intubation is a gold standard for intubation of a patient with anticipating difficult airway. This technique takes several minutes without oxygen supply, which results in hypoxia when it prolonged. If continuous supply of oxygen during procedure improve the oxygenation, we can reduce the risk of hypoxemia and increase the safety margin during procedure.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who have surgery under general oral endotracheal anesthesia with invasive arterial blood pressure monitoring

Exclusion Criteria:

  • history of lung disease
  • abnormality in chest x-ray
  • anticipating difficult intubation
  • pregnant women
  • who is unable to understand and agree the consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxygen
Oxygen is supplied through suction port in bronchoscope during bronchoscope-guided intubation.
Drug: Oxygen
Oxygen is supplied through suction port during bronchoscope-guided intubation.
No Intervention: Control
Bronchoscope-guided intubation is performed without oxygen supply.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Velocity of PaO2 decrease
Time Frame: from mask removal to 1st manual ventilation after intubation, up to 5 minute
After administration of anesthetic agents and manual ventilation of 5 minutes, arterial blood sampling is collected. Then bronchoscope-guided intubation performed and arterial blood sample is collected immediately after the intubation completed. Time for intubation (between 1st and 2nd blood sample) is recorded. The difference of PaO2(before & after intubation) is divided by the time taking for intubation.
from mask removal to 1st manual ventilation after intubation, up to 5 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success of intubation
Time Frame: 300 sec after the beginning of intubation
After 1st trial of intubation, the success of intubation is recorded. If it takes more than 300 sec, it will be considered failure.
300 sec after the beginning of intubation
PaO2
Time Frame: 1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
arterial blood samples are collected before and after intubation.
1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
PaCO2
Time Frame: 1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
arterial blood samples are collected before and after intubation.
1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
pH
Time Frame: 1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
arterial blood samples are collected before and after intubation.
1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
visual field
Time Frame: throughout the intubation with bronchoscope, upto 5 minute
Visual field is evaluated by the blinded observer. It is evaluated as followed;excellent, good, poor, impossible
throughout the intubation with bronchoscope, upto 5 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Study Chair: Jeong Soo Lee, MD, Yonsei University Gangnam Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

September 4, 2017

Study Completion (Actual)

September 4, 2017

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

December 6, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2015-0218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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