US airway: Sonographic Evaluation to Predict Difficult Airway Management

• Sponsor: Mongi Slim Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03991325
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 67.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Airway Management; Upper Airway Sonographic Evaluation	Diagnostic Test: upper airway sonography

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 Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Sonographic Evaluation to Predict Difficult Airway Management
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: May 30, 2019
• Actual Study Completion Date: May 30, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. prediction of difficult laryngoscopy with ultrasonographic criteria [5 min after induction of general anesthesia determined by Cormack and Lehane grade]

   incidence of difficult laryngoscopy

Secondary Outcome Measures

1. prediction of difficult mask ventilation with ultrasonographic criteria [3 min after induction of general anesthesia]

   Incidence of difficult ventilation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mongi Slim Hospital	La Marsa	Tunis	Tunisia	2046

Sponsors and Collaborators

• Mongi Slim Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mhamed Sami Mebazaa, Head of the anesthesia intensive care department, Mongi Slim Hospital
• ClinicalTrials.gov Identifier: NCT03991325
• Other Study ID Numbers: sonographic evaluation airway
• First Posted: Jun 19, 2019
• Last Update Posted: Jun 19, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 19, 2019