NCT02625194

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2017

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

1.7 years

First QC Date

November 25, 2015

Last Update Submit

July 8, 2019

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • success of intubation

    300 sec after the beginning of intubation

  • PaO2

    1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute

  • PaCO2

    1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute

  • pH

    1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute

  • visual field

    throughout the intubation with bronchoscope, upto 5 minute

Study Arms (2)

Oxygen

EXPERIMENTAL

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

Drug: Oxygen

Control

NO INTERVENTION

Bronchoscope-guided intubation is performed without oxygen supply.

Interventions

OxygenDRUG

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

Oxygen

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam severance hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33167909DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Jeong Soo Lee, MD

    Yonsei University Gangnam Severance Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 9, 2015

Study Start

January 1, 2016

Primary Completion

September 4, 2017

Study Completion

September 4, 2017

Last Updated

July 9, 2019

Record last verified: 2019-07

Locations

KR(1)