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Comparison of McGrath and Macintosh Laryngoscope for DLT Intubation

Primary Purpose

Intubation; Difficult, Thoracic Diseases, Intubation Complication

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
videolaryngoscope
Direct laryngoscope
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intubation; Difficult focused on measuring videolaryngoscope, double lumen intubation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients
  • Thoracic surgery required one lung ventilation

Exclusion Criteria:

  • Difficult ventilation
  • Emergent operation

Sites / Locations

  • Tongji Hospital, Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

videolaryngoscope

Direct laryngoscope

Arm Description

DLT intubation with McGrath videolaryngoscope

DLT intubation with Macintosh laryngoscope

Outcomes

Primary Outcome Measures

Intubation time
measured with a stopwatch, defined as time from inserting blade to mouth to withdrawal of blade

Secondary Outcome Measures

number of successful intubation at first attempt

Full Information

First Posted
July 10, 2014
Last Updated
November 19, 2014
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02190201
Brief Title
Comparison of McGrath and Macintosh Laryngoscope for DLT Intubation
Official Title
A Randomised Controlled Trial Comparing McGrath Series 5 Videolaryngoscope and Macintosh Laryngoscope for Double Lumen Tube Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. But it is not determined about the advantages and disadvantages of McGrath Series 5 videolaryngoscope for double-lumen tube intubation, compared with traditional Macintosh laryngoscope.
Detailed Description
The investigators designed a randomised controlled study to compare of McGrath Series 5 videolaryngoscope and Macintosh laryngoscope for DLT intubation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation; Difficult, Thoracic Diseases, Intubation Complication
Keywords
videolaryngoscope, double lumen intubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
videolaryngoscope
Arm Type
Experimental
Arm Description
DLT intubation with McGrath videolaryngoscope
Arm Title
Direct laryngoscope
Arm Type
Active Comparator
Arm Description
DLT intubation with Macintosh laryngoscope
Intervention Type
Device
Intervention Name(s)
videolaryngoscope
Other Intervention Name(s)
McGrath series 5 videolaryngoscope
Intervention Description
a kind of videolaryngoscopes, which are widely used in difficult airways.
Intervention Type
Device
Intervention Name(s)
Direct laryngoscope
Other Intervention Name(s)
Macintosh laryngoscopes
Intervention Description
A kind of traditional laryngoscopes
Primary Outcome Measure Information:
Title
Intubation time
Description
measured with a stopwatch, defined as time from inserting blade to mouth to withdrawal of blade
Time Frame
at intubation
Secondary Outcome Measure Information:
Title
number of successful intubation at first attempt
Time Frame
at intubation
Other Pre-specified Outcome Measures:
Title
Airway evaluation with Cormack-Lehane Score
Description
based on Cormack-Lehane classification. degree 1 to 4
Time Frame
At intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients Thoracic surgery required one lung ventilation Exclusion Criteria: Difficult ventilation Emergent operation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuke Tian, M.D.
Organizational Affiliation
Huazhong University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

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Comparison of McGrath and Macintosh Laryngoscope for DLT Intubation

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