Sonographic Evaluation to Predict Difficult Airway Management (US airway)

June 18, 2019 updated by: Mhamed Sami Mebazaa, Mongi Slim Hospital

the aim of this study was to evaluate the accuracy of different ultrasonographic parameters and clinical tests to predict difficult airway assessment.

Ultrasonographic parameters were: hyo-mental distence, tongue width, skin to epiglottis distence and skin to hyoid bone distence. these parameters were recorded and their predictive acurracy was studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

the aim of this study was to evaluate the accuracy of different ultrasonographic parameters and clinical tests to predict difficult airway assessment.

Ultrasonographic parameters were: hyo-mental distence, tongue width, skin to epiglottis distence and skin to hyoid bone distence. these parameters were recorded and their predictive acurracy was studied.

This study analyzed a sample size of 200 patients undergoing elective or urgent surgery under general anesthesia and recieving neuromuscular blocking agent before laryngoscopy.

the correlation between ultrasonographic parameters and difficult laryngoscopy was studied

Study Type

Observational

Enrollment (Actual)

200

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

  • Tunisia
    • Tunis
      • La Marsa, Tunis, Tunisia, 2046
        • Mongi Slim hospital

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

Sampling Method

Probability Sample

Study Population

Inclusion Criteria:

  • patients scheduled for orthopedic or viseral surgery under general anesthesia and tracheal intubation.

Exclusion Criteria:

  • patients with suspected tracheal stenosis
  • Patients with a poor quality ultrasonographic exam

Description

Inclusion Criteria:

  • patients scheduled for orthopedic or viseral surgery under general anesthesia and tracheal intubation.

Exclusion Criteria:

  • patients with suspected tracheal stenosis
  • Patients with a poor quality ultrasonographic exam

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
difficult laryngoscopy
group of patients with Cormack and Lehane grade III or IV
Diagnostic test: upper airway sonography
clinical evaluation of upper airway, ultrasonographic assessement
easy laryngoscopy
group of patients with Cormack and Lehane grade I or II
Diagnostic test: upper airway sonography
clinical evaluation of upper airway, ultrasonographic assessement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prediction of difficult laryngoscopy with ultrasonographic criteria
Time Frame: 5 min after induction of general anesthesia determined by Cormack and Lehane grade
incidence of difficult laryngoscopy
5 min after induction of general anesthesia determined by Cormack and Lehane grade

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prediction of difficult mask ventilation with ultrasonographic criteria
Time Frame: 3 min after induction of general anesthesia
Incidence of difficult ventilation
3 min after induction of general anesthesia

Collaborators and Investigators

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

Sponsor

Mongi Slim Hospital

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 (Actual)

March 1, 2019

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

May 30, 2019

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • sonographic evaluation airway

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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