Comparison of El-Ganzouri Risk Index and Airway Ultrasonographic Evaluation in Thyroid Surgery
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2024
CompletedFirst Submitted
Initial submission to the registry
April 4, 2024
CompletedFirst Posted
Study publicly available on registry
April 17, 2024
CompletedApril 17, 2024
April 1, 2024
5 months
April 4, 2024
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Find which is the best test predicts difficult intubation
Up to 6 months, until the end of the study
Finding the incidence of difficult intubation in thyroid surgery
Up to 6 months, until the end of the study
Study Arms (2)
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.
Difficult Intubation Not Expected
Patients who do not meet the criteria just mentioned
Interventions
EGRI scores and airway ultrasonographic values will be recorded in patients who undergo thyroid surgery.
Eligibility Criteria
A total of 120 patients, with ASA scores 1-3, aged between 18-65 years who undergo thyroid surgery will be included.
You may qualify if:
- Patients with ASA scores 1-3
- Patients between 18-65 age
- Patients who undergo thyroid surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800, Turkey (Türkiye)
Related Publications (5)
Langenstein H, Cunitz G. [Difficult intubation in adults]. Anaesthesist. 1996 Apr;45(4):372-83. doi: 10.1007/s001010050274. German.
PMID: 8702056RESULTBacuzzi 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.
PMID: 19195946RESULTAdhikari 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.
PMID: 21707828RESULTApfelbaum 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.
PMID: 34762729RESULTZheng 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.
PMID: 33591134RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Şeref Çelik
Ankara Bilkent City Hospital, Algology Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2024
First Posted
April 17, 2024
Study Start
June 1, 2023
Primary Completion
October 31, 2023
Study Completion
January 28, 2024
Last Updated
April 17, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share