Comparison of El-Ganzouri Risk Index and Airway Ultrasonographic Evaluation in Thyroid Surgery

Difficult Intubation Clinical Trial

Official title:

Comparison of El-Ganzouri Risk Index and Airway Ultrasonographic Evaluation In Terms of Predicting Difficult Intubation in Patients Undergoing Thyroid Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06369636
• Other study ID #: myucesu
• Status: Completed
• Start date: June 1, 2023
• Est. completion date: January 28, 2024

Study information

• Verified date: April 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 28, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficult Intubation
• Thyroid Diseases
• Thyroid Surgery

Intervention

Procedure:
• Thyroid Surgery
EGRI scores and airway ultrasonographic values will be recorded in patients who undergo thyroid surgery.

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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.1553-2712.2 — View 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 — View 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. — View Citation

Langenstein H, Cunitz G. [Difficult intubation in adults]. Anaesthesist. 1996 Apr;45(4):372-83. doi: 10.1007/s001010050274. German. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare EGRI and airway ultrasonographic parameters	Compare EGRI and airway ultrasonography for predicting difficult intubation in patients who undergoing thyroid surgery	Up to 6 months, until the end of the study
Secondary	Find which is the best test predicts difficult intubation	by comparing these tests to decide which test is the best predictor for difficult intubation in thyroid surgery	Up to 6 months, until the end of the study
Secondary	Finding the incidence of difficult intubation in thyroid surgery	Determine the incidence of difficult intubation in thyroid surgery	Up to 6 months, until the end of the study