- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02329041
Comparison of McGrath Series 5 and Airtraq Videolaryngoscope for Double-lumen Tube (DLT) Intubation
April 3, 2017 updated by: Wenlong Yao, Huazhong University of Science and Technology
A Randomised Controlled Trial Comparing of McGrath Series 5 and Airtraq Videolaryngoscope for Double-lumen Tube Intubation in Patients With Low Airway Risk Index Score
Previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation.
We have compared it with traditional Macintosh laryngoscopefor double-lumen tube intubation.
In this study, we will investigate its role in double-lumen tube intubation by comparison with another videolarygoscope.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The investigators designed a randomised controlled study to compare of McGrath Series 5 and Airtraq videolaryngoscope for DLT intubation in intubation time and the first attempt success rate.
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
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Tongji Hospital, Huazhong University of Science and Technology
-
-
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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients
- Thoracic surgery required one lung ventilation
Exclusion Criteria:
- ASA physical status >4
- Emergent operation
- planned tracheotomy
- difficult intubation predicted by a simplified airway risk index score
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: McGrath Series 5
DLT intubation with McGrath Series 5 videolaryngoscope
|
one kind of videolaryngoscopes, which are widely used in airway management.
|
|
Active Comparator: Airtraq
DLT intubation with Airtraq videolaryngoscope
|
another kind of videolaryngoscopes, which are also widely used in airway management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intubation time
Time Frame: at intubation
|
defined as time from inserting blade to mouth to withdrawal of blade, measured with a stopwatch
|
at intubation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of successful intubation at first attempt
Time Frame: at intubation
|
at intubation
|
|
total successful rate of DLT intubation
Time Frame: at intubation
|
at intubation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Airway evaluation with Cormack-Lehane Score
Time Frame: At intubation
|
based on Cormack-Lehane classification.
degree 1 to 4
|
At intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Yuke Tian, M.D., yktian@tjh.tjmu.edu.cn
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
January 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
December 21, 2014
First Submitted That Met QC Criteria
December 29, 2014
First Posted (Estimate)
December 31, 2014
Study Record Updates
Last Update Posted (Actual)
April 4, 2017
Last Update Submitted That Met QC Criteria
April 3, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJMZK201412002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Because the article has not been published.
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.