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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

Primary Purpose

Cholecystitis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fiberoptic bronchoscope
pentax-airway scope
semi-rigid collar
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cholecystitis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ajou University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

fiberoptic bronchoscope

fiberoptic bronchoscope with pentax-AWS

Arm Description

Tracheal intubation in patients with semi-rigid collar immobilization of the cervical spine using fiberoptic bronchoscope

Tracheal intubation in patients with semi-rigid collar immobilization of the cervical spine using fiberoptic bronchoscope with pentax-AWS

Outcomes

Primary Outcome Measures

time to intubation

Secondary Outcome Measures

ease of intubation
Numeric rating scale 0-10 (0:easy without any difficulty, 10: impossible to intubate)

Full Information

First Posted
June 16, 2016
Last Updated
June 26, 2017
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02827110
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fiberoptic bronchoscope
Arm Type
Active Comparator
Arm Description
Tracheal intubation in patients with semi-rigid collar immobilization of the cervical spine using fiberoptic bronchoscope
Arm Title
fiberoptic bronchoscope with pentax-AWS
Arm Type
Experimental
Arm Description
Tracheal intubation in patients with semi-rigid collar immobilization of the cervical spine using fiberoptic bronchoscope with pentax-AWS
Intervention Type
Device
Intervention Name(s)
fiberoptic bronchoscope
Intervention Description
Tracheal intubation using fiberoptic bronchoscope
Intervention Type
Device
Intervention Name(s)
pentax-airway scope
Intervention Description
Tracheal intubation using pentax-AWS
Intervention Type
Procedure
Intervention Name(s)
semi-rigid collar
Intervention Description
semi-rigid collar immobilization of the cervical spine
Primary Outcome Measure Information:
Title
time to intubation
Time Frame
Time from device passing the mouth until confirmation of tracheal intubation by bronchoscope will be measured, about 2 minutes
Secondary Outcome Measure Information:
Title
ease of intubation
Description
Numeric rating scale 0-10 (0:easy without any difficulty, 10: impossible to intubate)
Time Frame
Numeric rating scale will be assessed by practioner of fiberoptic bronchoscope for intubation immediately after intubation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ajou University School of Medicine
City
Suwon
State/Province
Gyeong-gi
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28981579
Citation
Kim DH, Yoo JY, Ha SY, Chae YJ. Comparison of the paediatric blade of the Pentax-AWS and Ovassapian airway in fibreoptic tracheal intubation in patients with limited mouth opening and cervical spine immobilization by a semi-rigid neck collar: a randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):993-999. doi: 10.1093/bja/aex272.
Results Reference
derived

Learn more about this trial

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

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