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Completed

NCT Number: NCT02625194

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

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

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam severance hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2015
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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