Midsagittal Tongue Measurement to Predict Difficult Airways

NCT05519358 | Completed

• 1 other identifier: SKara
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

An unanticipated difficult airway is a potentially life-threatening event during elective surgery or management of critical conditions. However, the common clinical screening tests, show low sensitivity and specificity with a limited predictive value. Recently, ultrasound has been used to identify difficult airway. Tongue volume is one of the parameters evaluated by ultrasound. In this study, we aim to evaluate the capacity of mid-sagittal tongue CSA and tongue width to predict difficult laryngoscopy and difficult intubation.

Conditions

Difficult Airway; Ultrasonography

Keywords

Airway management; Ultrasonography; Tongue widht

Outcome Measures

Primary Outcomes (2)

• midsagittal tongue cross- sectional area

  To evaluate the capability of midsagittal tongue cross- sectional area measured by ultrasound to predict difficult laryngoscopy and difficult intubation.

  All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.

• tongue width

  To evaluate the capability of tongue widht measured by ultrasound to predict difficult laryngoscopy and difficult intubation.

  All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.

Study Arms (2)

difficult airway

difficult laryngoscopy; Cormack-Lehane grades 3 or 4 or Difficult intubation; Intubation Difficulty Scale (IDS)\> 5 .IDS based on parameters known to be associated with difficult intubation

non difficult airway

not difficult intubation or laryngoscopy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are18 to 90 years old and of either sex who required general anesthesia with tracheal intubation for bariatric surgery .

You may qualify if:

• American Society of Anesthesiologists (ASA) physical condition I-II-III
• Patients are required general anesthesia with tracheal intubation for bariatric surgery.

You may not qualify if:

• Patients with maxillofacial deformity, trauma, or tumor
• Patients with identified difficult airway or difficult airway history
• Patients with cancellation of tracheal intubation for a non-difficult airway reason

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University Faculty of medicine

Samsun, 55040, Turkey (Türkiye)

Location

Related Publications (3)

• Moura ECR, Filho ASM, de Oliveira EJSG, Freire TT, da Cunha Leal P, de Sousa Gomes LMR, Servin ETN, de Oliveira CMB. Comparative Study of Clinical and Ultrasound Parameters for Defining a Difficult Airway in Patients with Obesity. Obes Surg. 2021 Sep;31(9):4118-4124. doi: 10.1007/s11695-021-05528-1. Epub 2021 Jul 5.

  PMID: 34227021 BACKGROUND

• 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 BACKGROUND

• Yao W, Wang B. Can tongue thickness measured by ultrasonography predict difficult tracheal intubation? Br J Anaesth. 2017 Apr 1;118(4):601-609. doi: 10.1093/bja/aex051.

  PMID: 28403413 BACKGROUND

Study Officials

• Suna KARAGÖRMÜŞ

  Samsun Univercity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 29, 2022
• Study Start: September 13, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 25, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)