McGrath Series 5 Videolaryngoscope for Double-lumen Tube... | NCT01984970

Studies
McGrath Series 5 Videolaryngoscope for Double-lumen Tube Intubation

NCT01984970

Sponsor

Huazhong University of Science and Technology

Status

Completed

Last Update Posted

Jul 14, 2014Estimated

Enrollment

43Actual

Phase

Not provided

Conditions

Intubation; Difficult
Intubation Complication

Interventions

videolaryngoscope

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

Jul 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

Nov 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Nov 1, 2013

First Submission Date that Met QC Criteria

Nov 7, 2013

First Posted Date

Nov 15, 2013Estimated

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

Jul 10, 2014

Last Update Posted Date

Jul 14, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wenlong Yao, M.D., Ph.D., Attending physician, 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

Double-lumen tube intubation is difficult, compared with single lume tube.
McGrath Series 5 videolaryngoscope hase been used in difficult airway management, both in anesthetized and awake patients.
But there was little information about McGrath Series 5 videolaryngoscope for double-lumen tube intubation.

Detailed Description

In this study, the purpose was to evaluate the success rate and intubation time of McGrath Series 5 videolaryngoscope for double-lumen tube intubation in patients without predictors of difficult intubation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
videolaryngoscope		The patients received videolaryngoscope for double-lumen tube intubation	Device: videolaryngoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
videolaryngoscope	Device	McGrath Series 5 videolaryngoscope is one kind of portable videolaryngoscopes, which has been usde in both unexpected and anticipated difficult intubation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intubation time	defined as time from inserting blade to mouth to three cycles on capnograph	at intubation

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
BMI		one day before operation
mouth opening	measure with a ruler	one day before operation
Thyromental distance

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients
thoracic surgery
ASA classification 1-3

Exclusion Criteria:

Emergent operation
predicted difficult airway
difficult ventilation
limited mouth opening

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

adult patients scheduled for thoracic surgery requiring double-lumen tube insertion for one-lung ventilation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuke Tian, Ph.D.,M.D.	Huazhong University of Science and Technology	Study Director

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24813140	Result	Yao WL, Wang XR, Xu H, Zhang Y, Zhang CH. McGrath((R)) series 5 videolaryngoscope evaluation for double-lumen tube intubation. Anaesthesia. 2014 Jun;69(6):646-7. doi: 10.1111/anae.12720. No abstract available.