NCT06369636

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 4, 2024

Last Update Submit

April 15, 2024

Conditions

Keywords

Thyroid SurgeryEl-Ganzouri Risk IndexAirway UltrasonographyDifficult Intubation

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.

Procedure: Thyroid Surgery

Difficult Intubation Not Expected

Patients who do not meet the criteria just mentioned

Procedure: Thyroid Surgery

Interventions

EGRI scores and airway ultrasonographic values will be recorded in patients who undergo thyroid surgery.

Difficult Intubation ExpectedDifficult Intubation Not Expected

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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)

Location

Related Publications (5)

  • 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 Officials

  • Şeref Çelik

    Ankara Bilkent City Hospital, Algology Clinic

    PRINCIPAL INVESTIGATOR

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

Locations