Curarisation and Intubation Conditions During Videolaryng... | NCT02404142

Studies
Curarisation and Intubation Conditions During Videolaryngoscopy With Glidescope Titanium

NCT02404142

Sponsor

CHU de Reims

Status

Completed

Last Update Posted

Jan 9, 2018Actual

Enrollment

64Actual

Phase

Phase 4

Conditions

Tracheal Intubation

Interventions

Curare (Atracurium)
saline isotonic solution

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

Status Module

Record Verification Date

Jan 2018

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

Feb 20, 2015

Primary Completion Date

Apr 5, 2016Actual

Completion Date

Aug 5, 2016Actual

First Submitted Date

Mar 17, 2015

First Submission Date that Met QC Criteria

Mar 30, 2015

First Posted Date

Mar 31, 2015Estimated

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

Jan 8, 2018

Last Update Posted Date

Jan 9, 2018Actual

Name	Class
Verathon	INDUSTRY

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

Detailed Description

In this prospective, randomized study, the investigators assess the intubation conditions during videolaryngoscopy with Glidescope Titanium whether patients receive (curare (Atracurium)group) or no (control group) within elective surgery patients with no difficult intubation prediction. The IDS score assessed by an anesthesiologist from the video-recording is the primary outcome. All general anesthesias are standardized using Target Control Infusion of propofol and sufentanil. The investigators also compare IDS scores as assessed by intubators, time for tracheal intubation, and laryngeal morbidity in both groups.

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

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group (saline isotonic solution)	Placebo Comparator	saline isotonic solution	Drug: saline isotonic solution
Curar (Atracurium) group	Experimental	Curar (Atracurium)	Drug: Curare (Atracurium)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Curare (Atracurium)	Drug	Curare (Atracurium) versus saline isotonic solution for tracheal intubation	Curar (Atracurium) group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IDS score video-assessed as described by Adnet et al. Measurement will be made by 2 experts anesthesiologists for centralized reading	Number of IDS scores <2 are compared	Assessment will be done at the end of the inclusions period (9 months)

Secondary Outcomes

Measure	Description	Time Frame
IDS score assesed by the intubator anesthesiologist		3 days post intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective Surgery Adult Patients
no difficult intubation prediction

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Chu de Reims		Reims		51092	France

Intervention Browse Module

MeSH Terms

ID	Term
D003472	Curare
D001279	Atracurium

Ancestor Terms

ID	Term
D010936	Plant Extracts
D028321	Plant Preparations
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided