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

Primary Purpose

Lumbar Spinal Stenosis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oxygen
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lumbar Spinal Stenosis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gangnam severance hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oxygen

Control

Arm Description

Oxygen is supplied through suction port in bronchoscope during bronchoscope-guided intubation.

Bronchoscope-guided intubation is performed without oxygen supply.

Outcomes

Primary Outcome Measures

Velocity of PaO2 decrease
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.

Secondary Outcome Measures

success 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.
PaO2
arterial blood samples are collected before and after intubation.
PaCO2
arterial blood samples are collected before and after intubation.
pH
arterial blood samples are collected before and after intubation.
visual field
Visual field is evaluated by the blinded observer. It is evaluated as followed;excellent, good, poor, impossible

Full Information

First Posted
November 25, 2015
Last Updated
July 8, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02625194
Brief Title
The Utility of Oxygen Insufflation During Flexible Fiberoptic Bronchoscope-guided Intubation
Official Title
The Utility of Oxygen Insufflation During Flexible Fiberoptic Bronchoscope-guided Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
September 4, 2017 (Actual)
Study Completion Date
September 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxygen
Arm Type
Experimental
Arm Description
Oxygen is supplied through suction port in bronchoscope during bronchoscope-guided intubation.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Bronchoscope-guided intubation is performed without oxygen supply.
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
Oxygen is supplied through suction port during bronchoscope-guided intubation.
Primary Outcome Measure Information:
Title
Velocity of PaO2 decrease
Description
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.
Time Frame
from mask removal to 1st manual ventilation after intubation, up to 5 minute
Secondary Outcome Measure Information:
Title
success of intubation
Description
After 1st trial of intubation, the success of intubation is recorded. If it takes more than 300 sec, it will be considered failure.
Time Frame
300 sec after the beginning of intubation
Title
PaO2
Description
arterial blood samples are collected before and after intubation.
Time Frame
1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
Title
PaCO2
Description
arterial blood samples are collected before and after intubation.
Time Frame
1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
Title
pH
Description
arterial blood samples are collected before and after intubation.
Time Frame
1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
Title
visual field
Description
Visual field is evaluated by the blinded observer. It is evaluated as followed;excellent, good, poor, impossible
Time Frame
throughout the intubation with bronchoscope, upto 5 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Soo Lee, MD
Organizational Affiliation
Yonsei University Gangnam Severance Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Gangnam severance hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33167909
Citation
Roh GU, Kang JG, Han JY, Chang CH. Utility of oxygen insufflation through working channel during fiberoptic intubation in apneic patients: a prospective randomized controlled study. BMC Anesthesiol. 2020 Nov 10;20(1):282. doi: 10.1186/s12871-020-01201-9.
Results Reference
derived

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

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