Difficult IntubationNCT06896513
Relationship of Isthmus Thickness With Difficult Laryngoscopy and Difficult Intubation in Patients Receiving Hypothyroidism Treatment
An observational study of Difficult Intubation and Difficult Laryngoscopy, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Under general anesthesia, the rate of failed intubation ranges from 1.5% to 13%, raising concerns among anesthesiologists whose primary goal is successful airway management. In this context, various physical and ultrasonographic measurement techniques have been developed to predict difficult intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Intubation, Difficult Laryngoscopy
- What is being tested?
- Isthmus
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2025to 4 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing surgery at Konya City Hospital for any reason Known hypothyroidism receiving medical treatment
Who may be able to join
- Known hypothyroidism receiving medical treatment
- ASA score of 2-3
Who cannot join
- Known history of difficult intubation
- Body mass index (BMI) > 40
- Presence of airway pathology
- Diseases that restrict neck movement (e.g., RA, SLE, AS, etc.)
- Head and neck range of motion ≤ 80°
- History of cervical radiotherapy
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship of Isthmus Thickness With Difficult Laryngoscopy and Difficult Intubation in Patients Receiving Hypothyroidism Treatment: A Prospective Observational Clinical Study
Under general anesthesia, the rate of failed intubation ranges from 1.5% to 13%, raising concerns among anesthesiologists whose primary goal is successful airway management. In this context, various physical and ultrasonographic measurement techniques have been developed to predict difficult intubation. Ultrasonography is effectively used for estimating tracheal tube size, device placement, diagnosing upper airway pathologies, and guiding percutaneous tracheostomy. In thyroid pathologies, intubation difficulty may increase; however, the impact of goiter remains debatable, as some conditions causing hypothyroidism are reported to lead to thyroid gland atrophy rather than hypertrophy. The study's hypothesis is that an atrophic or fibrotic thyroid isthmus may be associated with difficult laryngoscopy and intubation. Evaluation will be performed using the Cormack-Lehane score (Grade III-IV) and the Intubation Difficulty Scale (IDS >5). The aim is to determine the relationship between thyroid isthmus thickness and difficult laryngoscopy and intubation during elective intubation in patients receiving hypothyroidism treatment.
Preoperatively, patients' demographic and clinical data (age, gender, height, weight, BMI, comorbidities, ASA score, thyroid medication dose, treatment duration, and type of thyroid disease) will be recorded. In the premedication room, after administering 0.01 mg/kg IV midazolam, the distance between the thyroid isthmus and the skin will be measured using a linear ultrasound probe (3-13 Hz) in the supine position with neck hyperextension at the level of the 2nd-3rd tracheal rings; the average of three measurements will be recorded. In the operating room, under noninvasive monitoring and following mask pre-oxygenation, anesthesia induction will be performed using IV 2 mg/kg propofol, 1 µg/kg fentanyl, 1 mg/kg lidocaine, and 0.6 mg/kg rocuronium. Once the TOF reaches zero, an experienced anesthesiologist will intubate using a size 3 Macintosh blade for females and size 4 for males with an appropriate endotracheal tube. The intubation time, defined as the interval from laryngoscope insertion until the first capnography wave is detected, will be recorded along with the Cormack-Lehane and EZS scores and the requirement for video laryngoscopy. In cases of failed intubation, the 2022 ASA Difficult Airway Management Guidelines will be applied.
Read the detailed description
Under general anesthesia, the rate of failed intubation ranges between 1.5% and 13%, a high rate that raises concerns among anesthesiologists whose primary objective is successful airway management. Consequently, various physical examination and ultrasonographic measurement methods have been developed to predict difficult intubation. While anesthesiologists previously relied on bedside physical examinations, the widespread availability, reliability, and portability of ultrasound (USG) have promoted its use in airway evaluation. USG is used to assess the difficult airway, estimate tracheal tube size, ensure proper placement of the tracheal tube and laryngeal mask, diagnose upper airway pathologies, and guide percutaneous tracheostomy.
In thyroid pathologies, intubation difficulty may increase. Although difficult intubation rates in thyroid surgery-a known risk factor-range from 6.8% to 9.6%, some studies suggest that the presence of a goiter is not associated with difficult intubation. The literature has mostly examined the relationship between intubation difficulty and hypertrophic thyroid tissue; however, certain conditions causing hypothyroidism (e.g., Hashimoto's thyroiditis and atrophic thyroiditis) may lead to thyroid gland atrophy. Our hypothesis is that an atrophic or fibrotic thyroid isthmus is (or is not) associated with difficult laryngoscopy and intubation.
Difficult laryngoscopy is defined as the inability to visualize the vocal cords despite multiple laryngoscopic attempts. Tracheal intubation that requires multiple attempts or fails after several attempts is termed difficult or failed intubation. Evaluation will be performed using the Cormack-Lehane (C\&L) score and the Intubation Difficulty Scale (IDS). The C\&L score classifies the laryngeal view into four grades based on the visualization of the vocal cords and epiglottis (Grade I: full view of the glottis; Grade II: partial view; Grade III: only the epiglottis is visible; Grade IV: neither the epiglottis nor the glottis is visible), with Grades III-IV being associated with difficult laryngoscopy. The IDS, which consists of seven parameters, indicates a difficult airway when the score exceeds 5. Accordingly, a C\&L classification of Grade III-IV and an IDS >5 will be considered indicative of difficult laryngoscopy and intubation.
The primary aim of this study is to determine the relationship between thyroid isthmus thickness and difficult laryngoscopy and intubation during elective intubation in patients receiving hypothyroidism treatment. The primary hypothesis is that an atrophic or fibrotic thyroid isthmus is associated with difficult laryngoscopy and intubation, while the secondary hypothesis posits that the duration of hypothyroidism treatment is associated with difficult laryngoscopy and intubation.
This study will include adult patients with known hypothyroidism who are undergoing surgery for any reason at Konya City Hospital and are receiving medical treatment, with an ASA score of 2-3. Patients will be excluded if they have a known history of difficult intubation, a body mass index (BMI) >40, airway pathology, conditions that restrict neck movements (e.g., rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis), a cervical range of motion ≤80°, a history of cervical radiotherapy, or if they do not consent to participate. The primary objective is to evaluate the efficacy of thyroid isthmus muscle thickness in predicting difficult intubation in goiter patients undergoing thyroidectomy.
Preoperatively, patients' age, gender, height (cm), weight (kg), BMI, comorbidities, ASA score, thyroid medication dose, duration of hypothyroidism treatment (years), and type of thyroid disease (Hashimoto's thyroiditis, atrophic thyroiditis, multinodular goiter, malignant goiter) will be recorded. In the premedication room, after administering 0.01 mg/kg IV midazolam, the neck skin thickness from the thyroid isthmus to the skin will be measured in millimeters using a linear ultrasound probe (3-13 Hz) in the supine position with neck hyperextension. Measurements will be taken in a transverse view at the level of the 2nd-3rd tracheal rings, and the average of three measurements will be recorded.
In the operating room, patients will be monitored using noninvasive blood pressure, pulse oximetry, electrocardiography, bispectral index (BIS), and neuromuscular monitoring (TOF). Following mask pre-oxygenation, anesthesia induction will be performed with IV 2 mg/kg propofol, 1 µg/kg fentanyl, 1 mg/kg lidocaine, and 0.6 mg/kg rocuronium. Once the TOF value reaches zero, an experienced anesthesiologist will intubate the patient using an appropriately sized endotracheal tube with a size 3 Macintosh blade for females and a size 4 for males, following proper head positioning. The intubation time-defined as the interval from laryngoscope insertion until the first capnography waveform is detected-will be recorded. Additionally, the patients' Cormack-Lehane and IDS scores, as well as the need for video laryngoscopy, will be documented. In the event of failed intubation, management will be conducted in accordance with the 2022 ASA Difficult Airway Management Guidelines (e.g., summoning assistance, optimizing oxygenation, selecting an invasive or noninvasive approach, considering combination techniques, limiting the number of intubation or supraglottic airway placement attempts to prevent potential injury and complications, ensuring that any invasive airway procedure is performed by a trained individual as rapidly as possible, and initiating ECMO when appropriate/available).
- Conditions
- Difficult Intubation, Difficult Laryngoscopy
- Being tested
- Isthmus
- Keywords
- Intubation, Laryngoscopy, Isthmus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsthmusOther
The neck skin thickness from the thyroid isthmus to the skin will be measured in millimeters using a linear ultrasound probe (3-13 Hz) in the supine position with neck hyperextension. Measurements will be taken in a transverse view at the level of the 2nd-3rd tracheal rings, and the average of three measurements will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with known hypothyroidism who are receiving medical treatment and are scheduled for e | Adult patients with known hypothyroidism who are receiving medical treatment and are scheduled for elective intubation. Receives: Other: Isthmus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack-Lehane score and Intubation Difficulty Scale values of patients whose isthmus thickness is below 3 mm.
Measured: From enrollment to the end of treatment at 6 Mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start25 Apr 2025
- Primary completion4 Mar 2026
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Keklicek, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896513
- Sponsor's protocol ID
- 2024/5150
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Isthmus Thickness With Difficult Laryngoscopy and Difficult Intubation in Patients Receiving Hypothyroidism Treatment: A Prospective Observational Clinical Study
- ClinicalTrials.gov ID
- NCT06896513
- Acronym / sponsor ID
- 2024/5150
- Conditions
- Difficult Intubation, Difficult Laryngoscopy
- Keywords
- Intubation, Laryngoscopy, Isthmus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 26 Mar 2025 (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.
Under general anesthesia, the rate of failed intubation ranges from 1.5% to 13%, raising concerns among anesthesiologists whose primary goal is successful airway management. In this context, various physical and ultrasonographic measurement techniques have been developed to predict difficult intubation. Ultrasonography is effectively used for estimating tracheal tube size, device placement, diagnosing upper airway pathologies, and guiding percutaneous tracheostomy. In thyroid pathologies, intubation difficulty may increase; however, the impact of goiter remains debatable, as some conditions causing hypothyroidism are reported to lead to thyroid gland atrophy rather than hypertrophy. The study's hypothesis is that an atrophic or fibrotic thyroid isthmus may be associated with difficult laryngoscopy and intubation. Evaluation will be performed using the Cormack-Lehane score (Grade III-IV) and the Intubation Difficulty Scale (IDS >5). The aim is to determine the relationship between thyroid isthmus thickness and difficult laryngoscopy and intubation during elective intubation in patients receiving hypothyroidism treatment.
Preoperatively, patients' demographic and clinical data (age, gender, height, weight, BMI, comorbidities, ASA score, thyroid medication dose, treatment duration, and type of thyroid disease) will be recorded. In the premedication room, after administering 0.01 mg/kg IV midazolam, the distance between the thyroid isthmus and the skin will be measured using a linear ultrasound probe (3-13 Hz) in the supine position with neck hyperextension at the level of the 2nd-3rd tracheal rings; the average of three measurements will be recorded. In the operating room, under noninvasive monitoring and following mask pre-oxygenation, anesthesia induction will be performed using IV 2 mg/kg propofol, 1 µg/kg fentanyl, 1 mg/kg lidocaine, and 0.6 mg/kg rocuronium. Once the TOF reaches zero, an experienced anesthesiologist will intubate using a size 3 Macintosh blade for females and size 4 for males with an appropriate endotracheal tube. The intubation time, defined as the interval from laryngoscope insertion until the first capnography wave is detected, will be recorded along with the Cormack-Lehane and EZS scores and the requirement for video laryngoscopy. In cases of failed intubation, the 2022 ASA Difficult Airway Management Guidelines will be applied.
Detailed description
Under general anesthesia, the rate of failed intubation ranges between 1.5% and 13%, a high rate that raises concerns among anesthesiologists whose primary objective is successful airway management. Consequently, various physical examination and ultrasonographic measurement methods have been developed to predict difficult intubation. While anesthesiologists previously relied on bedside physical examinations, the widespread availability, reliability, and portability of ultrasound (USG) have promoted its use in airway evaluation. USG is used to assess the difficult airway, estimate tracheal tube size, ensure proper placement of the tracheal tube and laryngeal mask, diagnose upper airway pathologies, and guide percutaneous tracheostomy.
In thyroid pathologies, intubation difficulty may increase. Although difficult intubation rates in thyroid surgery-a known risk factor-range from 6.8% to 9.6%, some studies suggest that the presence of a goiter is not associated with difficult intubation. The literature has mostly examined the relationship between intubation difficulty and hypertrophic thyroid tissue; however, certain conditions causing hypothyroidism (e.g., Hashimoto's thyroiditis and atrophic thyroiditis) may lead to thyroid gland atrophy. Our hypothesis is that an atrophic or fibrotic thyroid isthmus is (or is not) associated with difficult laryngoscopy and intubation.
Difficult laryngoscopy is defined as the inability to visualize the vocal cords despite multiple laryngoscopic attempts. Tracheal intubation that requires multiple attempts or fails after several attempts is termed difficult or failed intubation. Evaluation will be performed using the Cormack-Lehane (C\&L) score and the Intubation Difficulty Scale (IDS). The C\&L score classifies the laryngeal view into four grades based on the visualization of the vocal cords and epiglottis (Grade I: full view of the glottis; Grade II: partial view; Grade III: only the epiglottis is visible; Grade IV: neither the epiglottis nor the glottis is visible), with Grades III-IV being associated with difficult laryngoscopy. The IDS, which consists of seven parameters, indicates a difficult airway when the score exceeds 5. Accordingly, a C\&L classification of Grade III-IV and an IDS >5 will be considered indicative of difficult laryngoscopy and intubation.
The primary aim of this study is to determine the relationship between thyroid isthmus thickness and difficult laryngoscopy and intubation during elective intubation in patients receiving hypothyroidism treatment. The primary hypothesis is that an atrophic or fibrotic thyroid isthmus is associated with difficult laryngoscopy and intubation, while the secondary hypothesis posits that the duration of hypothyroidism treatment is associated with difficult laryngoscopy and intubation.
This study will include adult patients with known hypothyroidism who are undergoing surgery for any reason at Konya City Hospital and are receiving medical treatment, with an ASA score of 2-3. Patients will be excluded if they have a known history of difficult intubation, a body mass index (BMI) >40, airway pathology, conditions that restrict neck movements (e.g., rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis), a cervical range of motion ≤80°, a history of cervical radiotherapy, or if they do not consent to participate. The primary objective is to evaluate the efficacy of thyroid isthmus muscle thickness in predicting difficult intubation in goiter patients undergoing thyroidectomy.
Preoperatively, patients' age, gender, height (cm), weight (kg), BMI, comorbidities, ASA score, thyroid medication dose, duration of hypothyroidism treatment (years), and type of thyroid disease (Hashimoto's thyroiditis, atrophic thyroiditis, multinodular goiter, malignant goiter) will be recorded. In the premedication room, after administering 0.01 mg/kg IV midazolam, the neck skin thickness from the thyroid isthmus to the skin will be measured in millimeters using a linear ultrasound probe (3-13 Hz) in the supine position with neck hyperextension. Measurements will be taken in a transverse view at the level of the 2nd-3rd tracheal rings, and the average of three measurements will be recorded.
In the operating room, patients will be monitored using noninvasive blood pressure, pulse oximetry, electrocardiography, bispectral index (BIS), and neuromuscular monitoring (TOF). Following mask pre-oxygenation, anesthesia induction will be performed with IV 2 mg/kg propofol, 1 µg/kg fentanyl, 1 mg/kg lidocaine, and 0.6 mg/kg rocuronium. Once the TOF value reaches zero, an experienced anesthesiologist will intubate the patient using an appropriately sized endotracheal tube with a size 3 Macintosh blade for females and a size 4 for males, following proper head positioning. The intubation time-defined as the interval from laryngoscope insertion until the first capnography waveform is detected-will be recorded. Additionally, the patients' Cormack-Lehane and IDS scores, as well as the need for video laryngoscopy, will be documented. In the event of failed intubation, management will be conducted in accordance with the 2022 ASA Difficult Airway Management Guidelines (e.g., summoning assistance, optimizing oxygenation, selecting an invasive or noninvasive approach, considering combination techniques, limiting the number of intubation or supraglottic airway placement attempts to prevent potential injury and complications, ensuring that any invasive airway procedure is performed by a trained individual as rapidly as possible, and initiating ECMO when appropriate/available).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with known hypothyroidism who are receiving medical treatment and are scheduled for e | – | Other: IsthmusAdult patients with known hypothyroidism who are receiving medical treatment and are scheduled for elective intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing surgery at Konya City Hospital for any reason Known hypothyroidism receiving medical treatment
Key inclusion criteria (2 listed)
- Known hypothyroidism receiving medical treatment
- ASA score of 2-3
Key exclusion criteria (7 listed)
- Known history of difficult intubation
- Body mass index (BMI) > 40
- Presence of airway pathology
- Diseases that restrict neck movement (e.g., RA, SLE, AS, etc.)
- Head and neck range of motion ≤ 80°
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 |
|---|---|---|
| IsthmusThe neck skin thickness from the thyroid isthmus to the skin will be measured in millimeters using a linear ultrasound probe (3-13 Hz) in the supine position with neck hyperextension. Measurements will be taken in a transverse view at the level of the 2nd-3rd tracheal rings, and the average of three measurements will be recorded. | Other | Adult patients with known hypothyroidism who are receiving medical treatment and are scheduled for e |
Primary outcome
Cormack-Lehane score and Intubation Difficulty Scale values of patients whose isthmus thickness is below 3 mm.
Time frame: From enrollment to the end of treatment at 6 Mounths
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 13 Apr 2026.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Difficult Intubation and Difficult Laryngoscopy, run by Konya City Hospital 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 2 inclusion and 7 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 13 Apr 2026. 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?
Cormack-Lehane score and Intubation Difficulty Scale values of patients whose isthmus thickness is below 3 mm. (time frame: From enrollment to the end of treatment at 6 Mounths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.