Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes

NCT03592758 | Completed

• 1 other identifier: UEDAM
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Airway Complication of Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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".

Study Arms (1)

ultrasound assessment

all patient are evaluated by an ultrasound assessment before general anaesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patient \> 18 ys undergoing general anesthesia for elective surgery

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Policlinico Umberto I - UNiversità Sapienzadi Roma

Roma, 00100, Italy

Location

Related Publications (1)

• 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.

  PMID: 31742568 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 19, 2018
• Study Start: June 1, 2017
• Primary Completion: June 10, 2018
• Study Completion: June 14, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

IT (1)