Midsagittal Tongue Measurement to Predict Difficult Airways

NCT ID: NCT05519358

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-13

Study Completion Date

2024-03-25

Brief Summary

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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.

Detailed Description

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Anatomical changes that adversely affect airway accessibility due to increased adipose tissue in obese patients make it difficult to establish an advanced airway by orotracheal intubation. Difficulty with airway management for anesthesia has potentially serious implications, as failure to secure a patent airway can result in hypoxic brain injury or death in a matter of minutes. There have been no effective methods to predict difficult airways accurately. Ultrasonography is a non-invasive, safe, and painless modality for evaluating soft tissues. In recent years, studies have been carried out on the parameters that can be used in determining the difficult airway with ultrasound. These include the distance from the skin to the epiglottis, the tongue thickness, the tongue volume, the mandibular condylar mobility, and the visibility of the hyoid. Few studies have whether midsagittal tongue cross section area and tongue width can also be used to predict difficult airways similarly to tongue volume. Therefore, this study was designed to evaluate the predictive value of accurately measured tongue thickness and cross-sectional tongue area using ultrasonography for predicting difficult tracheal intubation and difficult laryngoscopy.

Conditions

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Difficult Airway Ultrasonography

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

non difficult airway

not difficult intubation or laryngoscopy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsun University

OTHER

Sponsor Role lead

Responsible Party

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Suna Kara Gormus

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suna KARAGÖRMÜŞ

Role: PRINCIPAL_INVESTIGATOR

Samsun Univercity

Locations

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Samsun University Faculty of medicine

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 34227021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31742568 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28403413 (View on PubMed)

Other Identifiers

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SKara

Identifier Type: -

Identifier Source: org_study_id

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