Study of Interest on Cervical Ultrasound Exploration for Association With Difficult Intubation

Intubation; Difficult Clinical Trial

— TUBECHO  

Official title:

Human Study of Interest on Cervical Ultrasound Exploration for Association With Criteria of Difficult Intubation in General Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362568
• Other study ID #: P/2013/181
• Status: Completed
• Phase: N/A
• First received: January 28, 2014
• Last updated: August 30, 2016
• Start date: October 2013
• Est. completion date: April 2015

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria.

Description:

The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria in general surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18

• patient consent

Exclusion Criteria:

• patient nonconsent

• age under 18

• cervical surgery

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Procedure:
• Ultrasound cervical exploration
The cervical ultrasound exploration will consist in the ultrasound measurement of the length between the hyoid bone and the skin and the length between the thyroid cartilage and the skin. The ultrasound cervical exploration will be performed in all patients admitted in the postoperative room after a planned surgery performed under general anesthesia.

Locations

Country	Name	City	State
France	CHU Besancon Minjoz	Besancon
France	CHRU de Besançon	Besançon	Franche Comte

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensibility, Specificity, predictive positive and negative values of US cervical measures relationship between the hyoid bone and thyroid cartilage with difficult intubation	The measure of the length between the hyoid bone and the skin and between the thyroid cartilage and the skin will be measured using an ultrasound cervical exploration in all patients admitted in the postoperative room after planned surgery performed under general anesthesia.	Day 1	Yes
Secondary	Sensibility, specificity and predictive positive and negative values of validated clinical criteria for difficult intubation	The collect of usual clinical criteria of difficult intubation in postoperative room of patients who undergo a general anesthesia for a surgery	Day 1	Yes
Secondary	Mortality and morbidity of difficult intubation	Collect any complications (hypoxia, hypotension, tooth breakage) assigned to a difficult intubation during general anesthesia for surgery.	Day 1	Yes