NCT03991325

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

June 17, 2019

Last Update Submit

June 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • prediction of difficult laryngoscopy with ultrasonographic criteria

    incidence of difficult laryngoscopy

    5 min after induction of general anesthesia determined by Cormack and Lehane grade

Secondary Outcomes (1)

  • prediction of difficult mask ventilation with ultrasonographic criteria

    3 min after induction of general anesthesia

Study Arms (2)

difficult laryngoscopy

group of patients with Cormack and Lehane grade III or IV

Diagnostic Test: upper airway sonography

easy laryngoscopy

group of patients with Cormack and Lehane grade I or II

Diagnostic Test: upper airway sonography

Interventions

clinical evaluation of upper airway, ultrasonographic assessement

difficult laryngoscopyeasy laryngoscopy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mongi Slim Hospital

La Marsa, Tunis Governorate, 2046, Tunisia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the anesthesia intensive care department

Study Record Dates

First Submitted

June 17, 2019

First Posted

June 19, 2019

Study Start

March 1, 2019

Primary Completion

May 30, 2019

Study Completion

May 30, 2019

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations