UltrasonographyNCT07628868
The Impact of Ultrasound Measurements in Predicting Difficult Airway on Videolaryngoscopy Success
An observational study of Ultrasonography and Difficult Airway, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this preoperative observational study, the effect of preoperative ultrasonographic measurements on the success of videolaryngoscopy in predicting difficult airways was investigated; furthermore, the aim was to determine new cut-off values that can predict difficult intubation in videolaryngoscope use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasonography, Difficult Airway
- How many people
- 350 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2025to 20 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation
Who may be able to join
- Patients aged 18 years and older
- Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation (ASA I-III)
Who cannot join
- Patients undergoing surgery under sedation or regional anesthesia
- Patients not planned for endotracheal intubation
- Patients with a history of difficult airway
- Patients with an acute respiratory tract infection
- Patients with congenital or acquired upper airway anomalies
- Patients with facial or maxillofacial tumors or fractures
Show all 11Show fewer
- Patients with cervical spine fracture
- Patients with a history of cervical or craniofacial radiotherapy
- Patients with a tracheostomy
- Pregnant patients
- Patients who do not meet the required fasting period or who refuse to -participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul, Bakirköy, 34147
About this study
Official title: Impact of Airway Ultrasound Measurements on the Success of Videolaryngoscopy in Predicting Difficult Airway
In this preoperative observational study, the effect of preoperative ultrasonographic measurements on the success of videolaryngoscopy in predicting difficult airways was investigated; furthermore, the aim was to determine new cut-off values that can predict difficult intubation in videolaryngoscope use. In our study, it was tested that the use of videolaryngoscope significantly increased the success of intubation in patients who were assessed as having difficult airways with upper airway ultrasound measurements.
Read the detailed description
Upper airway ultrasonography has emerged as a promising tool for difficult airway assessment by enabling non-invasive, bedside, repeatable, and objective evaluation of airway anatomy. However, a substantial proportion of the existing literature has correlated ultrasonographic measurements with direct laryngoscopy findings. Whether these measurements retain their predictive value in the setting of videolaryngoscopy, and which ultrasonographic parameters best reflect technical intubation difficulty during videolaryngoscopic intubation, remain unclear. Furthermore, several studies have proposed specific cut-off values for upper airway ultrasonographic measurements to predict difficult laryngoscopy when direct laryngoscopy is used. However, these cut-off values may not be directly applicable to videolaryngoscopy because the improved glottic visualization provided by videolaryngoscopes fundamentally alters the relationship between airway anatomy and intubation difficulty.
Therefore, after obtaining a detailed medical history, including both general medical and difficult airway-related history, all patients underwent a comprehensive airway assessment. Conventional predictors of difficult airway were evaluated, including Mallampati classification, inter-incisor distance, thyromental distance, atlanto-occipital joint extension, neck circumference, and the upper lip bite test.
On the day of surgery, ultrasonographic measurements including the distance from the skin to the epiglottis (ESD), hyomental distance (HMD), tongue thickness (TT), and tongue cross-sectional area (CSA) will be obtained. Following these assessments, patients will be transferred to the operating room, where standard general anesthesia induction will be performed. Orotracheal intubation will subsequently be carried out using a videolaryngoscope. After intubation, the difficulty of mask ventilation, laryngoscopy, and orotracheal intubation will be evaluated by the anesthesiologist using established clinical assessment tools and scoring systems.
- Conditions
- Ultrasonography, Difficult Airway
- Keywords
- Difficult airway, Ultrasonography, Difficult laryngoscopy, Difficult mask ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| None (Orotracheal intubation will be performed using a videolaryngoscope in all patients) | Patients aged 18 years and older, classified as American Society of Anesthesiologists (ASA) physical status I-III, who will undergo surgery under general anesthesia requiring orotracheal intubation, will be included in this prospective observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult videolaryngoscopic intubation
Difficult videolaryngoscopic intubation will be assessed using the VIDIAC score, a scoring system specifically developed to quantify intubation difficulty during videolaryngoscopy.
Measured: During videolaryngoscopy (periprocedural)
Secondary outcomes (1)
Difficult mask ventilation
Difficult mask ventilation will be assessed after anesthesia induction and during ventilation.
Measured: During ventilation (periprocedural)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start21 Dec 2025
- Primary completion10 Jun 2026 (estimated)
- Study completion20 Jul 2026 (estimated)
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 UltrasonographyStudies 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gokhan Sertcakacilar, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628868
- Sponsor's protocol ID
- 2025/46
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study contains personal health information and no regulatory or ethics approval has been obtained for external data sharing.
Publications
Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.
PubMed 25403231Kheterpal S, Han R, Tremper KK, Shanks A, Tait AR, O'Reilly M, Ludwig TA. Incidence and predictors of difficult and impossible mask ventilation. Anesthesiology. 2006 Nov;105(5):885-91. doi: 10.1097/00000542-200611000-00007.
PubMed 17065880Gomes SH, Simoes AM, Nunes AM, Pereira MV, Teoh WH, Costa PS, Kristensen MS, Teixeira PM, Pego JM. Useful Ultrasonographic Parameters to Predict Difficult Laryngoscopy and Difficult Tracheal Intubation-A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 May 28;8:671658. doi: 10.3389/fmed.2021.671658. eCollection 2021.
PubMed 34124099Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.
PubMed 19293691Apfelbaum 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 34762729
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Airway Ultrasound Measurements on the Success of Videolaryngoscopy in Predicting Difficult Airway
- ClinicalTrials.gov ID
- NCT07628868
- Acronym / sponsor ID
- 2025/46
- Conditions
- Ultrasonography, Difficult Airway
- Keywords
- Difficult airway, Ultrasonography, Difficult laryngoscopy, Difficult mask ventilation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 21 Dec 2025 (actual)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 5 Jun 2026 (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.
In this preoperative observational study, the effect of preoperative ultrasonographic measurements on the success of videolaryngoscopy in predicting difficult airways was investigated; furthermore, the aim was to determine new cut-off values that can predict difficult intubation in videolaryngoscope use. In our study, it was tested that the use of videolaryngoscope significantly increased the success of intubation in patients who were assessed as having difficult airways with upper airway ultrasound measurements.
Detailed description
Upper airway ultrasonography has emerged as a promising tool for difficult airway assessment by enabling non-invasive, bedside, repeatable, and objective evaluation of airway anatomy. However, a substantial proportion of the existing literature has correlated ultrasonographic measurements with direct laryngoscopy findings. Whether these measurements retain their predictive value in the setting of videolaryngoscopy, and which ultrasonographic parameters best reflect technical intubation difficulty during videolaryngoscopic intubation, remain unclear. Furthermore, several studies have proposed specific cut-off values for upper airway ultrasonographic measurements to predict difficult laryngoscopy when direct laryngoscopy is used. However, these cut-off values may not be directly applicable to videolaryngoscopy because the improved glottic visualization provided by videolaryngoscopes fundamentally alters the relationship between airway anatomy and intubation difficulty.
Therefore, after obtaining a detailed medical history, including both general medical and difficult airway-related history, all patients underwent a comprehensive airway assessment. Conventional predictors of difficult airway were evaluated, including Mallampati classification, inter-incisor distance, thyromental distance, atlanto-occipital joint extension, neck circumference, and the upper lip bite test.
On the day of surgery, ultrasonographic measurements including the distance from the skin to the epiglottis (ESD), hyomental distance (HMD), tongue thickness (TT), and tongue cross-sectional area (CSA) will be obtained. Following these assessments, patients will be transferred to the operating room, where standard general anesthesia induction will be performed. Orotracheal intubation will subsequently be carried out using a videolaryngoscope. After intubation, the difficulty of mask ventilation, laryngoscopy, and orotracheal intubation will be evaluated by the anesthesiologist using established clinical assessment tools and scoring systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| None (Orotracheal intubation will be performed using a videolaryngoscope in all patients) | – | –Patients aged 18 years and older, classified as American Society of Anesthesiologists (ASA) physical status I-III, who will undergo surgery under general anesthesia requiring orotracheal intubation, will be included in this prospective observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation
Key inclusion criteria (2 listed)
- Patients aged 18 years and older
- Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation (ASA I-III)
Key exclusion criteria (11 listed)
- Patients undergoing surgery under sedation or regional anesthesia
- Patients not planned for endotracheal intubation
- Patients with a history of difficult airway
- Patients with an acute respiratory tract infection
- Patients with congenital or acquired upper airway anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difficult videolaryngoscopic intubation
Time frame: During videolaryngoscopy (periprocedural)
Difficult videolaryngoscopic intubation will be assessed using the VIDIAC score, a scoring system specifically developed to quantify intubation difficulty during videolaryngoscopy.
1 secondary outcome
Difficult mask ventilation
Time frame: During ventilation (periprocedural)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 25403231Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.
- Background: PubMed 17065880Kheterpal S, Han R, Tremper KK, Shanks A, Tait AR, O'Reilly M, Ludwig TA. Incidence and predictors of difficult and impossible mask ventilation. Anesthesiology. 2006 Nov;105(5):885-91. doi: 10.1097/00000542-200611000-00007.
- Background: PubMed 34124099Gomes SH, Simoes AM, Nunes AM, Pereira MV, Teoh WH, Costa PS, Kristensen MS, Teixeira PM, Pego JM. Useful Ultrasonographic Parameters to Predict Difficult Laryngoscopy and Difficult Tracheal Intubation-A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 May 28;8:671658. doi: 10.3389/fmed.2021.671658. eCollection 2021.
- Background: PubMed 19293691Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.
- Background: 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study contains personal health information and no regulatory or ethics approval has been obtained for external data sharing.
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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 Ultrasonography and Difficult Airway, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 11 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Difficult videolaryngoscopic intubation (time frame: During videolaryngoscopy (periprocedural)). 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 NCT07628868, 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 5 Jun 2026.