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

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625194
• Other study ID #: 3-2015-0218
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis

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