NCT02362568

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
462

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
1 year until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

1.5 years

First QC Date

January 28, 2014

Last Update Submit

August 30, 2016

Conditions

Intubation; Difficult

Keywords

Intubation; Difficult

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Sensibility, specificity and predictive positive and negative values of validated clinical criteria for difficult intubation

    Day 1

  • Mortality and morbidity of difficult intubation

    Day 1

Study Arms (1)

Cervical ultrasound exploration

NO INTERVENTION

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

Interventions

Ultrasound cervical explorationPROCEDURE

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.

Cervical ultrasound exploration

Eligibility Criteria

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

You may qualify if:

  • Age over 18
  • patient consent

You may not qualify if:

  • patient nonconsent
  • age under 18
  • cervical surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Besançon

Besançon, Franche Comte, 25000, France

Location

CHU Besancon Minjoz

Besançon, 25000, France

Location

Study Officials

  • Boinette Romain, MD

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2014

First Posted

February 13, 2015

Study Start

October 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

FR(2)