Intubation; Difficult or FailedNCT06928402
Comparison of Airway Ultrasound Measurements
An observational study of Intubation; Difficult or Failed, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Evaluating the success of measurements taken with ultrasound airway imaging in predicting difficult intubation by comparing conventional parameters in terms of difficult intubation and the proportion of patients encountered during intubation and characterised as difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult or Failed
- How many people
- 420 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2025to 10 Sep 2025
- 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: All cases that meet the inclusion and exclusion criteria will be included in the study. Patients will be taken to the operating room after being preoperatively evaluated in the observation room. The patient's anesthetic management will be provided by another anesthesiologist who is not participating in the study and is responsible for the patient. Intraoperative data will be obtained from the patient's anaesthesia follow-up form and the records of the anaesthesia machine. This group will include patients who will be intubated and operated on under general anaesthesia.
Who may be able to join
- Patients to be operated with endotracheal intubation under elective conditions
- Voluntary patients whose informed consent was obtained,
- Patients older than 18 years
- Patients evaluated in the 1-2-3 category of the American Society of Anaesthesiologist (ASA)
Who cannot join
- Patients with a history of difficult intubation
- Pregnant patients
- Patients with a history of surgery in the head and neck region
- Patients with a history of trauma or tumour in the head and neck region
- Presence of a syndrome that will cause difficult intubation
- Uncooperative patients,
- Patients with missing data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Ataturk Sanatorium Research and Training Hospital
Ankara
About this study
Official title: Comparison of Airway Ultrasound Measurements With Conventional Parameters in Predicting Difficult Intubation
Evaluating the success of measurements taken with ultrasound airway imaging in predicting difficult intubation by comparing conventional parameters in terms of difficult intubation and the proportion of patients encountered during intubation and characterised as difficult.
Read the detailed description
Clinical screening tests, which have long been routinely used for airway assessment, do not have sufficient sensitivity and specificity to detect difficult laryngoscopy. The Cormack-Lehane laryngoscopy classification, which can be assessed during direct laryngoscopy, is an invasive procedure and is not suitable for routine preoperative airway assessment. Preoperative airway assessment using ultrasound can help to predict a difficult laryngoscopy and/or difficult intubation and is growing in popularity as a non-invasive diagnostic tool. Several recent studies have emphasised the importance of various ultrasound-mediated airway measurements in predicting difficult intubation, and have shown that measurements with different parameters and data obtained by ratioing some measurements to each other may have an important role. However, the parameters obtained by ultrasound-mediated airway measurement can help determine airway anatomy and guide airway interventions with dynamic real-time images.
In this study, investigators used hyoid bone visibility obtained through preoperative ultrasound evaluation of the upper airway, followed by measurements of the skin-hyoid distance, skin-cricothyroid membrane distance and length, and hyomental distance in two different positions-neutral and extension. The ratios of these measurements were analyzed to predict difficult intubation. Traditional parameters commonly used as indicators of difficult ventilation and/or intubation, such as the Mallampati-Samsoon classification, upper lip bite test, thyromental distance, sternomental distance, neck circumference, maximum mouth opening, Wilson difficult intubation score, and Han ventilation scale, were also included in the study.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- No intervention
- Keywords
- airway management, airway ultrasound, difficult intubation, difficult ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
no interventions will be performed by the research team
| Study group | Role | What they receive |
|---|---|---|
| Airway Measurement Group | As this study is observational in nature, no interventions will be performed by the research team. The study will ,nvolve a single group, within which the incidence and prevalence of the outcomes will be assessed. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of ultrasound-derived parameters with conventional parameters
ultrasound derived parameters: hyoid bone visibility, skin-hyoid distance, skin-hyoid distance, skin-crricothyroid membrane distance, cricothyroid membrane length and hyomental distance measured in neutral and extension and the ratio of these values.
Conventional parameters: thyromental distance, sternomental distance, upper lip bite test, head-neck movement, presence of retrognathia, neck circumference, maximum mouth opening, Wilson difficult intubation score, Han scale and Mallampati score
Measured: 1 hour peroperatively
Secondary outcomes (2)
Incidence of difficult intubation
Defined as ≥3 intubation attempts by an experienced anesthesiologist, use of adjunctive devices (e.g., stylet, LMA, video laryngoscope), or duration >10 minutes.
Measured: 1 hour peroperatively
Incidence of difficult ventilation
Grade 3 and 4 for Han scale.( Difficulty of mask ventilation (DMV) has been classified using the Han scale.)
Measured: 1 hour preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start14 Apr 2025
- Primary completion31 Aug 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies 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
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Munire BABAYIGIT, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- Münire Babayiğit, MD, Principal investigator, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928402
- Sponsor's protocol ID
- SK001
- Status last verified
- Sep 2025
- First submitted
- 8 Apr 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Airway Ultrasound Measurements With Conventional Parameters in Predicting Difficult Intubation
- ClinicalTrials.gov ID
- NCT06928402
- Acronym / sponsor ID
- SK001
- Conditions
- Intubation; Difficult or Failed
- Keywords
- airway management, airway ultrasound, difficult intubation, difficult ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 15 Apr 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.
Evaluating the success of measurements taken with ultrasound airway imaging in predicting difficult intubation by comparing conventional parameters in terms of difficult intubation and the proportion of patients encountered during intubation and characterised as difficult.
Detailed description
Clinical screening tests, which have long been routinely used for airway assessment, do not have sufficient sensitivity and specificity to detect difficult laryngoscopy. The Cormack-Lehane laryngoscopy classification, which can be assessed during direct laryngoscopy, is an invasive procedure and is not suitable for routine preoperative airway assessment. Preoperative airway assessment using ultrasound can help to predict a difficult laryngoscopy and/or difficult intubation and is growing in popularity as a non-invasive diagnostic tool. Several recent studies have emphasised the importance of various ultrasound-mediated airway measurements in predicting difficult intubation, and have shown that measurements with different parameters and data obtained by ratioing some measurements to each other may have an important role. However, the parameters obtained by ultrasound-mediated airway measurement can help determine airway anatomy and guide airway interventions with dynamic real-time images.
In this study, investigators used hyoid bone visibility obtained through preoperative ultrasound evaluation of the upper airway, followed by measurements of the skin-hyoid distance, skin-cricothyroid membrane distance and length, and hyomental distance in two different positions-neutral and extension. The ratios of these measurements were analyzed to predict difficult intubation. Traditional parameters commonly used as indicators of difficult ventilation and/or intubation, such as the Mallampati-Samsoon classification, upper lip bite test, thyromental distance, sternomental distance, neck circumference, maximum mouth opening, Wilson difficult intubation score, and Han ventilation scale, were also included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airway Measurement Group | – | Other: No interventionAs this study is observational in nature, no interventions will be performed by the research team. The study will ,nvolve a single group, within which the incidence and prevalence of the outcomes will be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cases that meet the inclusion and exclusion criteria will be included in the study. Patients will be taken to the operating room after being preoperatively evaluated in the observation room. The patient's anesthetic management will be provided by another anesthesiologist who is not participating in the study and is responsible for the patient. Intraoperative data will be obtained from the patient's anaesthesia follow-up form and the records of the anaesthesia machine. This group will include patients who will be intubated and operated on under general anaesthesia.
Key inclusion criteria (4 listed)
- Patients to be operated with endotracheal intubation under elective conditions
- Voluntary patients whose informed consent was obtained,
- Patients older than 18 years
- Patients evaluated in the 1-2-3 category of the American Society of Anaesthesiologist (ASA)
Key exclusion criteria (7 listed)
- Patients with a history of difficult intubation
- Pregnant patients
- Patients with a history of surgery in the head and neck region
- Patients with a history of trauma or tumour in the head and neck region
- Presence of a syndrome that will cause difficult intubation
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 |
|---|---|---|
| No interventionno interventions will be performed by the research team | Other | Airway Measurement Group |
Primary outcome
Ratio of ultrasound-derived parameters with conventional parameters
Time frame: 1 hour peroperatively
ultrasound derived parameters: hyoid bone visibility, skin-hyoid distance, skin-hyoid distance, skin-crricothyroid membrane distance, cricothyroid membrane length and hyomental distance measured in neutral and extension and the ratio of these values. Conventional parameters: thyromental distance, sternomental distance, upper lip bite test, head-neck movement, presence of retrognathia, neck circumference, maximum mouth opening, Wilson difficult intubation score, Han scale and Mallampati score
2 secondary outcomes
Incidence of difficult intubation
Time frame: 1 hour peroperatively
Incidence of difficult ventilation
Time frame: 1 hour preoperatively
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 19 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Intubation; Difficult or Failed
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Difficult Airway Prediction by Integrating STOP-BANG Criteria
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Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
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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.
Münire Babayiğit, MD principal investigator
Ankara Ataturk Sanatorium Training and Research Hospital
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 Intubation; Difficult or Failed, run by Ankara Ataturk Sanatorium Training and Research 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 4 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 19 Sep 2025. 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?
Ratio of ultrasound-derived parameters with conventional parameters (time frame: 1 hour peroperatively). 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 19 Sep 2025.