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

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

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.

Study Overview

• Status: Completed
• Conditions: Difficult Intubation; Thyroid Surgery
• Intervention / Treatment: Procedure: 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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06800
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Difficult Intubation Expected; Patients whose EGRI scores are equal or greater than 4, or whose skin to epiglottis measurement are greater than 18 mm, skin to hyoid bone measurement are greater than 14 mm, skin to anterior commissure of vocal cords are greater than 13 mm, tongue thickness are greater than 60 mm and tongue volume greater than 100 cm3.	Procedure: Thyroid Surgery; EGRI scores and airway ultrasonographic values will be recorded in patients who undergo thyroid surgery.
Difficult Intubation Not Expected; Patients who do not meet the criteria just mentioned	Procedure: Thyroid Surgery; EGRI scores and airway ultrasonographic values will be recorded in patients who undergo thyroid surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Şeref Çelik, Ankara Bilkent City Hospital, Algology Clinic

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): January 28, 2024

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Difficult Intubation; Thyroid Surgery; El-Ganzouri Risk Index; Airway Ultrasonography
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: myucesu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No