McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope | NCT02292901

Studies
McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope

NCT02292901

Sponsor

Hopital Foch

Status

Terminated

Last Update Posted

Oct 31, 2016Estimated

Enrollment

158Actual

Phase

Not Applicable

Conditions

Tracheal Intubation

Interventions

Macintosh laryngoscope
McGrath Mac videolaryngoscope

Countries

France

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

ID	Type	Description	Link
2013-A01307-38	Other Identifier	ANSM

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Nov 2015Actual

Completion Date

May 2016Actual

First Submitted Date

Nov 12, 2014

First Submission Date that Met QC Criteria

Nov 17, 2014

First Posted Date

Nov 18, 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

Oct 28, 2016

Last Update Posted Date

Oct 31, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Videolaryngoscopes become widely used. The aim of this study is to compare McGrath Mac videolaryngoscope to conventional MacIntosh laryngoscope in patients without known risk of difficult of mask ventilation and of tracheal intubation.

Detailed Description

Not provided

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

158Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Macintosh laryngoscope	Active Comparator	Tracheal intubation will be performed using a Macintosh laryngoscope	Device: Macintosh laryngoscope
McGrath Mac videolaryngoscope	Experimental	Tracheal intubation will be performed using a McGrath Mac videolaryngoscope	Device: McGrath Mac videolaryngoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Macintosh laryngoscope	Device		Macintosh laryngoscope
McGrath Mac videolaryngoscope

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ease of tracheal intubation	Ease of intubation is measured using the Intubation Difficulty Scale (Adnet et al. Anesthesiology 1997;87(6):1290-1297)	1 hour

Secondary Outcomes

Measure	Description	Time Frame
Time to obtain the first capnogram (sec)		one hour
Score of Cormak and Lehane modified by Yentis		one hour
POGO (percentage of glottic opening) score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient scheduled for a general anesthesia with orotracheal intubation

Exclusion Criteria:

predictable risk of difficult mask ventilation or of difficult tracheal intubation
necessity of a rapid sequence induction
contra-indication to sufentanil, to propofol, or to atracurium
ENT, thoracic surgery, or intracranial surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 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
Michel Chandon, MD	Hopital Foch	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Hospitalier Franco-Britannique		Levallois-Perret	Hauts de Seine	92300	France
Hopital Foch