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

August 30, 2016 updated by: Centre Hospitalier Universitaire de Besancon

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

462

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • CHU Besancon Minjoz
    • Franche Comte
      • Besançon, Franche Comte, France, 25000
        • CHRU De Besancon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 18
  • patient consent

Exclusion Criteria:

  • patient nonconsent
  • age under 18
  • cervical surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Cervical ultrasound exploration
A cervical ultrasound exploration will be performed in all patients admitted for a planned surgery performed under general anesthesia during the stay in the postoperative room.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensibility, Specificity, predictive positive and negative values of US cervical measures relationship between the hyoid bone and thyroid cartilage with difficult intubation
Time Frame: Day 1
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensibility, specificity and predictive positive and negative values of validated clinical criteria for difficult intubation
Time Frame: Day 1
The collect of usual clinical criteria of difficult intubation in postoperative room of patients who undergo a general anesthesia for a surgery
Day 1
Mortality and morbidity of difficult intubation
Time Frame: Day 1
Collect any complications (hypoxia, hypotension, tooth breakage) assigned to a difficult intubation during general anesthesia for surgery.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Boinette Romain, MD, Centre Hospitalier Universitaire de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimate)

February 13, 2015

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P/2013/181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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