NCT02404142

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2016

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

March 17, 2015

Last Update Submit

January 8, 2018

Conditions

Tracheal Intubation

Keywords

Trachel intubationIDS scoreVideoaryngoscopyGlidescope® Titanium®NMBACurare (Atracurium)

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • IDS score assesed by the intubator anesthesiologist

    3 days post intubation

Study Arms (2)

Control group (saline isotonic solution)

PLACEBO COMPARATOR

saline isotonic solution

Drug: saline isotonic solution

Curar (Atracurium) group

EXPERIMENTAL

Curar (Atracurium)

Drug: Curare (Atracurium)

Interventions

Curare (Atracurium)DRUG

Curare (Atracurium) versus saline isotonic solution for tracheal intubation

Curar (Atracurium) group
saline isotonic solutionDRUG
Control group (saline isotonic solution)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective Surgery Adult Patients
  • no difficult intubation prediction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

MeSH Terms

Interventions

CurareAtracurium

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesBenzylisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2015

First Posted

March 31, 2015

Study Start

February 20, 2015

Primary Completion

April 5, 2016

Study Completion

August 5, 2016

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

FR(1)