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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02625194
Other study ID # 3-2015-0218
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date September 4, 2017

Study information

Verified date July 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date September 4, 2017
Est. primary completion date September 4, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Gangnam severance hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. from mask removal to 1st manual ventilation after intubation, up to 5 minute
Secondary 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. 300 sec after the beginning of intubation
Secondary PaO2 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
Secondary PaCO2 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
Secondary pH 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
Secondary visual field 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
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