Thyroid SurgeryNCT06369636
Comparison of El-Ganzouri Risk Index and Airway Ultrasonographic Evaluation in Thyroid Surgery
An observational study of Thyroid Surgery and Difficult Intubation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Surgery, Difficult Intubation
- What is being tested?
- Thyroid Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 28 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 120 patients, with ASA scores 1-3, aged between 18-65 years who undergo thyroid surgery will be included.
Who may be able to join
- Patients with ASA scores 1-3
- Patients between 18-65 age
- Patients who undergo thyroid surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Surgery, Difficult Intubation
- Being tested
- Thyroid Surgery
- Keywords
- Thyroid Surgery, El-Ganzouri Risk Index, Airway Ultrasonography, Difficult Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid SurgeryProcedure or surgery
EGRI scores and airway ultrasonographic values will be recorded in patients who undergo thyroid surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Thyroid Surgery | |
| Difficult Intubation Not Expected | Patients who do not meet the criteria just mentioned Receives: Procedure: Thyroid Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare EGRI and airway ultrasonographic parameters
Compare EGRI and airway ultrasonography for predicting difficult intubation in patients who undergoing thyroid surgery
Measured: Up to 6 months, until the end of the study
Secondary outcomes (2)
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
Measured: 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
Measured: Up to 6 months, until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jun 2023
- Primary completion31 Oct 2023
- Study completion28 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thyroid SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Şeref Çelik, Principal investigator, Ankara Bilkent City Hospital, Algology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369636
- Sponsor's protocol ID
- myucesu
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langenstein H, Cunitz G. [Difficult intubation in adults]. Anaesthesist. 1996 Apr;45(4):372-83. doi: 10.1007/s001010050274. German.
PubMed 8702056Bacuzzi 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.
PubMed 19195946Adhikari 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.
PubMed 21707828Apfelbaum 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.
PubMed 34762729Zheng 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.
PubMed 33591134
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of El-Ganzouri Risk Index and Airway Ultrasonographic Evaluation In Terms of Predicting Difficult Intubation in Patients Undergoing Thyroid Surgery
- ClinicalTrials.gov ID
- NCT06369636
- Acronym / sponsor ID
- myucesu
- Conditions
- Thyroid Surgery, Difficult Intubation
- Keywords
- Thyroid Surgery, El-Ganzouri Risk Index, Airway Ultrasonography, Difficult Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difficult Intubation Expected | – | Procedure: Thyroid SurgeryPatients 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 | – | Procedure: Thyroid SurgeryPatients who do not meet the criteria just mentioned |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 120 patients, with ASA scores 1-3, aged between 18-65 years who undergo thyroid surgery will be included.
Key inclusion criteria (3 listed)
- Patients with ASA scores 1-3
- Patients between 18-65 age
- Patients who undergo thyroid surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid SurgeryEGRI scores and airway ultrasonographic values will be recorded in patients who undergo thyroid surgery. | Procedure or surgery | Difficult Intubation Expected, Difficult Intubation Not Expected |
Primary outcome
Compare EGRI and airway ultrasonographic parameters
Time frame: Up to 6 months, until the end of the study
Compare EGRI and airway ultrasonography for predicting difficult intubation in patients who undergoing thyroid surgery
2 secondary outcomes
Find which is the best test predicts difficult intubation
Time frame: Up to 6 months, until the end of the study
Finding the incidence of difficult intubation in thyroid surgery
Time frame: Up to 6 months, until the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Results publication: PubMed 8702056Langenstein H, Cunitz G. [Difficult intubation in adults]. Anaesthesist. 1996 Apr;45(4):372-83. doi: 10.1007/s001010050274. German.
- Results publication: PubMed 19195946Bacuzzi 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.
- Results publication: PubMed 21707828Adhikari 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.
- Results publication: PubMed 34762729Apfelbaum 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.
- Results publication: PubMed 33591134Zheng 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.
- Individual participant dataSharing planned: No
Related trials for Thyroid Surgery
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingPhase 2
Zanzalintinib for the Treatment of Advanced Thyroid Cancer Before Surgery
Neoadjuvant Treatment, Thyroid Cancer
Recruiting
Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy
Thyroid Diseases, Ambulation Time
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
Enrolling by invitation
Effect of Cold Water Spray on Swallowing Difficulty, Pain, and Thirst After Thyroid Surgery
Swallowing Difficulties, Thirst
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şeref Çelik principal investigator
Ankara Bilkent City Hospital, Algology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Surgery and Difficult Intubation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare EGRI and airway ultrasonographic parameters (time frame: Up to 6 months, until the end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369636, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.