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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02404142
Other study ID # PI14034
Secondary ID
Status Completed
Phase Phase 4
First received March 17, 2015
Last updated January 8, 2018
Start date February 20, 2015
Est. completion date August 5, 2016

Study information

Verified date January 2018
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date August 5, 2016
Est. primary completion date April 5, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Elective Surgery Adult Patients

- no difficult intubation prediction

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Curare (Atracurium)
Curare (Atracurium) versus saline isotonic solution for tracheal intubation
saline isotonic solution


Locations

Country Name City State
France Chu de Reims Reims

Sponsors (2)

Lead Sponsor Collaborator
CHU de Reims Verathon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 IDS score assesed by the intubator anesthesiologist 3 days post intubation
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