Comparison of McGrath Series 5 and Airtraq Videolaryngosc... | NCT02329041

Studies
Comparison of McGrath Series 5 and Airtraq Videolaryngoscope for Double-lumen Tube (DLT) Intubation

NCT02329041

Sponsor

Huazhong University of Science and Technology

Status

Completed

Last Update Posted

Apr 4, 2017Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Intubation;Difficult
Thoracic Disease
Intubation Complication

Interventions

McGrath Series 5
Airtraq

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Apr 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Dec 21, 2014

First Submission Date that Met QC Criteria

Dec 29, 2014

First Posted Date

Dec 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2017

Last Update Posted Date

Apr 4, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wenlong Yao, M.D., Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
McGrath Series 5	Experimental	DLT intubation with McGrath Series 5 videolaryngoscope	Device: McGrath Series 5
Airtraq	Active Comparator	DLT intubation with Airtraq videolaryngoscope	Device: Airtraq

Interventions

Name	Type	Description	Arm Group Labels	Other Names
McGrath Series 5	Device	one kind of videolaryngoscopes, which are widely used in airway management.	McGrath Series 5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intubation time	defined as time from inserting blade to mouth to withdrawal of blade, measured with a stopwatch	at intubation

Secondary Outcomes

Measure	Description	Time Frame
number of successful intubation at first attempt		at intubation
total successful rate of DLT intubation		at intubation

Other Outcomes

Measure	Description	Time Frame
Airway evaluation with Cormack-Lehane Score	based on Cormack-Lehane classification. degree 1 to 4	At intubation

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuke Tian, M.D.	yktian@tjh.tjmu.edu.cn	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital, Huazhong University of Science and Technology		Wuhan	Hubei	430030	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Because the article has not been published.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013896	Thoracic Diseases

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided