Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone

June 26, 2017 updated by: yun jeong chae, Ajou University School of Medicine
A semi-rigid cervical collar is recommended for immobilization of the cervical spine in patients with cervical spine injury. It has been suggested that a reduction in mouth opening is the major contributing factor to the deterioration in the glottic view obtained. Fiberoptic intubation is among the most versatile techniques for managing both the anticipated and the unanticipated difficult airway. Recently, combination of fiberoptic bronchoscope with videolaryngoscope has been suggested to permit visual control of the passage of the tube over the fibrescope into the laryngeal inlet. The aim of this study is to compare the intubation time and ease of intubation between fiberoptic bronchoscope alone and bronchoscope with pentax airwayscope.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeong-gi
      • Suwon, Gyeong-gi, Korea, Republic of
        • Ajou University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologist physical status class I, II

Exclusion Criteria:

  • uncontrolled or limited cardiovascular disease
  • abnormality of airway
  • necessity for rapid sequence induction
  • BMI > 30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: fiberoptic bronchoscope
Tracheal intubation in patients with semi-rigid collar immobilization of the cervical spine using fiberoptic bronchoscope
Device: fiberoptic bronchoscope
Tracheal intubation using fiberoptic bronchoscope
Procedure: semi-rigid collar
semi-rigid collar immobilization of the cervical spine
Experimental: fiberoptic bronchoscope with pentax-AWS
Tracheal intubation in patients with semi-rigid collar immobilization of the cervical spine using fiberoptic bronchoscope with pentax-AWS
Device: fiberoptic bronchoscope
Tracheal intubation using fiberoptic bronchoscope
Procedure: semi-rigid collar
semi-rigid collar immobilization of the cervical spine
Device: pentax-airway scope
Tracheal intubation using pentax-AWS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to intubation
Time Frame: Time from device passing the mouth until confirmation of tracheal intubation by bronchoscope will be measured, about 2 minutes
Time from device passing the mouth until confirmation of tracheal intubation by bronchoscope will be measured, about 2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ease of intubation
Time Frame: Numeric rating scale will be assessed by practioner of fiberoptic bronchoscope for intubation immediately after intubation.
Numeric rating scale 0-10 (0:easy without any difficulty, 10: impossible to intubate)
Numeric rating scale will be assessed by practioner of fiberoptic bronchoscope for intubation immediately after intubation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-DE2-16-060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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