- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07628868
The Impact of Ultrasound Measurements in Predicting Difficult Airway on Videolaryngoscopy Success
Impact of Airway Ultrasound Measurements on the Success of Videolaryngoscopy in Predicting Difficult Airway
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bakirköy
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Istanbul, Bakirköy, Turkey (Türkiye), 34147
- SBÜ Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years and older
- Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation (ASA I-III)
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difficult videolaryngoscopic intubation
Time Frame: During videolaryngoscopy (periprocedural)
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Difficult videolaryngoscopic intubation will be assessed using the VIDIAC score, a scoring system specifically developed to quantify intubation difficulty during videolaryngoscopy.
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During videolaryngoscopy (periprocedural)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difficult mask ventilation
Time Frame: During ventilation (periprocedural)
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Difficult mask ventilation will be assessed after anesthesia induction and during ventilation.
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During ventilation (periprocedural)
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Collaborators and Investigators
Publications and helpful links
General Publications
- Kheterpal 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.
- Kheterpal 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.
- 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.
- 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.
- Gomes 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025/46
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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