Comparison of McGrath and Macintosh Laryngoscope for DLT... | NCT02190201

Studies
Comparison of McGrath and Macintosh Laryngoscope for DLT Intubation

NCT02190201

Sponsor

Huazhong University of Science and Technology

Status

Completed

Last Update Posted

Nov 21, 2014Estimated

Enrollment

114Actual

Phase

Phase 4

Conditions

Intubation; Difficult
Thoracic Diseases
Intubation Complication

Interventions

videolaryngoscope
Direct laryngoscope

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

Nov 2014

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

Jul 2014

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Jul 10, 2014

First Submission Date that Met QC Criteria

Jul 11, 2014

First Posted Date

Jul 15, 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

Nov 19, 2014

Last Update Posted Date

Nov 21, 2014Estimated

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

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.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
videolaryngoscope	Experimental	DLT intubation with McGrath videolaryngoscope	Device: videolaryngoscope
Direct laryngoscope	Active Comparator	DLT intubation with Macintosh laryngoscope	Device: Direct laryngoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
videolaryngoscope	Device	a kind of videolaryngoscopes, which are widely used in difficult airways.	videolaryngoscope

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
number of successful intubation at first attempt		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:

Difficult ventilation
Emergent operation

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.	Huazhong University of Science and Technology	Study Chair

Locations

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

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