Clinical trial NCT06369636: Comparison of El-Ganzouri Risk Index and Airway Ultrasonographic Evaluation in Thyroid Surgery
Official title: Comparison of El-Ganzouri Risk Index and Airway Ultrasonographic Evaluation In Terms of Predicting Difficult Intubation in Patients Undergoing Thyroid Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Surgery
Difficult Intubation
Keywords: Thyroid Surgery
El-Ganzouri Risk Index
Airway Ultrasonography
Difficult Intubation
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 120 patients, with ASA scores 1-3, aged between 18-65 years who undergo thyroid surgery will be included.

Brief summary: The primary purpose of this prospective observational study was to compare these tests used to predict difficult intubation in patients undergoing thyroid surgery. Secondarily; By comparing these tests, we aim to find the test that best predicts difficult intubation and to determine the incidence of difficult intubation in patients who will undergo thyroid surgery.

Detailed description: Patients' demographic information (age, gender, American Society of Anesthesiologists (ASA) classification, STOP-BANG score(snoring, feeling tired, observed apnea, hypertension, obesity, age, neck circumference and gender), body mass index) and thyroid ultrasonographic measurement will be recorded.

At the preoperative visit, patients will be evaluated for El-Ganzouri Risk Index (EGRI) scores (mouth opening, thyromental distance, mallampati score, neck movement limitation, presence of prognathia, body weight and history of difficult intubation) and for airway ultrasonography (skin-epiglottis distance, skin-hyoid bone distance, skin-vocal cord distance, tongue thickness and tongue volume values).

After this information is recorded, patients will be grouped as those expected difficult intubation and those who are not. After the patients are taken to the operating table and monitored, vascular access will be opened, standard anesthesia induction will be applied to the patients by the room specialist, and laryngoscopy and endotracheal intubation will be performed by the trained (\>2 years experienced) anesthesiologist. If Intubation Difficulty Scale (IDS) score will be greater than 5, patient will be considered difficult intubation.

Eligibility criteria: Inclusion Criteria:

* Patients with ASA scores 1-3
* Patients between 18-65 age
* Patients who undergo thyroid surgery

Exclusion Criteria:

* Patients who do not accept to participate the research
* Patients under age 18 and over age 65
* Pregnant patients
* Patients who undergo surgery due to emergency medical conditions (such as hematoma, thyroid crisis or myxedema coma)
* Patients with airway malformations
* Patients with a high risk of aspiration

Primary outcomes:
measure: Compare EGRI and airway ultrasonographic parameters
timeFrame: Up to 6 months, until the end of the study
Secondary outcomes:
measure: Find which is the best test predicts difficult intubation
timeFrame: Up to 6 months, until the end of the study
measure: Finding the incidence of difficult intubation in thyroid surgery
timeFrame: Up to 6 months, until the end of the study
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
affiliation: Ankara Bilkent City Hospital, Algology Clinic
name: Şeref Çelik
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langenstein H, Cunitz G. [Difficult intubation in adults]. Anaesthesist. 1996 Apr;45(4):372-83. doi: 10.1007/s001010050274. German.
citation: Bacuzzi A, Dionigi G, Del Bosco A, Cantone G, Sansone T, Di Losa E, Cuffari S. Anaesthesia for thyroid surgery: perioperative management. Int J Surg. 2008;6 Suppl 1:S82-5. doi: 10.1016/j.ijsu.2008.12.013. Epub 2008 Dec 13.
citation: Adhikari S, Zeger W, Schmier C, Crum T, Craven A, Frrokaj I, Pang H, Shostrom V. Pilot study to determine the utility of point-of-care ultrasound in the assessment of difficult laryngoscopy. Acad Emerg Med. 2011 Jul;18(7):754-8. doi: 10.1111/j.1553-2712.2011.01099.x. Epub 2011 Jun 27.
citation: Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.
citation: Zheng Z, Ma W, Du R. Effectiveness and validity of midsagittal tongue cross-sectional area and width measured by ultrasound to predict difficult airways. Minerva Anestesiol. 2021 Apr;87(4):403-413. doi: 10.23736/S0375-9393.20.14769-2. Epub 2021 Feb 16.