Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes

evaluate the efficacy of the ultrasound approach in predicting difficult mask ventilation in a heterogeneous population of patients undergoing general anesthesia.

Study Overview

• Status: Completed
• Conditions: Airway Complication of Anesthesia

Detailed Description

Preoperative ultrasound of the upper airway and detection of 5 ultrasound measurements:

Trachea-skin distance at the level of the thyroid isthmus; Trachea-skin distance at the jugular level Front commissure-skin distance; Distance from skin to the thyroid membrane Distance between hyoid bone and skin. Comparison of this measurement with HAN-scale for prediction of difficult mask ventilation during general anesthesia

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00100
    • Policlinico Umberto I - UNiversità Sapienzadi Roma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patient > 18 ys undergoing general anesthesia for elective surgery

Description

Inclusion Criteria:

- all patient > 18years old undergoing general anesthesia for elective surgery

Exclusion Criteria:

• Patients with fractures of the bones of the facial mass;
• Patients with laryngeal tumors
• Patients previously undergoing demolition of the larynx or neck;
• Tracheostomized patients;
• Pregnancy;
• Inter-incisive distance <3 cm;
• severely limited cervical mobility;
• Patients who are not given muscle relaxants
• Patient rejection.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ultrasound assessment; all patient are evaluated by an ultrasound assessment before general anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ultrasound assessment	the association between the ultrasound measurement and the difficulty of mask ventilation measured with the "Han scale". "Han scale" classify mask-ventilation in five grade of progressive difficulty: 0) mask ventilation did not attempt, 1) easy 2) difficult and requiring oral airway 3) very difficult requiring two practitioners 4) unable to mask ventilate. "Han scale" is the only grading scale available used routinely in anesthesiologic assessment of bag-mask ventilation.	Ultrasound assessment will be performed 30 minutes before induction of general anaesthesia and the mask ventilation evaluation will be performed 3 minutes after induction with ''Han scale".

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Publications and helpful links

General Publications

• Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): June 10, 2018
• Study Completion (Actual): June 14, 2018

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: UEDAM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No