Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes

Airway Complication of Anesthesia Clinical Trial

Official title:

Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592758
• Other study ID #: UEDAM
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: June 14, 2018

Study information

• Verified date: July 2018
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 14, 2018
• Est. primary completion date: June 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Airway Complication of Anesthesia

Locations

Country	Name	City	State
Italy	Policlinico Umberto I - UNiversità Sapienzadi Roma	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".