- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07383610
Ultrasound Predictors of Difficult Airway in Adults
Investigation of Ultrasonographic Predictors of Difficult Intubation and Difficult Mask Ventilation in Adult Patients
Study Overview
Status
Detailed Description
This prospective observational cohort study was conducted to evaluate the predictive value of preoperative ultrasonographic airway measurements for difficult intubation and difficult mask ventilation in adult patients undergoing elective surgery under general anesthesia. A total of 400 patients aged 18-70 years with ASA physical status I-III were included. Before induction of anesthesia, standard clinical airway assessment tests were recorded, and ultrasound measurements were performed to assess airway-related anatomical structures. Ultrasonographic parameters included skin-to-epiglottis distance, skin-to-thyroid cartilage distance, thyroid cartilage-to-epiglottis distance, pre-epiglottic space depth, tongue thickness, and hyomental distance measurements.
Intraoperatively, mask ventilation and intubation conditions were documented. Difficult intubation was defined as requiring two or more intubation attempts. Difficult mask ventilation was defined as the need for two-handed mask ventilation or inability to ventilate adequately using a face mask. The primary objective was to determine the association between ultrasonographic measurements and difficult intubation
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kütahya
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Kütahya, Kütahya, Turkey (Türkiye), 3100
- Kütahya Health Sciences University
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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:
- Age 18-70 years
ASA physical status I-III
Elective surgery under general anesthesia requiring orotracheal intubation
Written informed consent
Exclusion Criteria:
- Refusal to participate
Emergency surgery
Pregnancy
Known upper airway pathology or previous airway surgery
Restricted mouth opening (<3 cm)
Cervical spine instability or significant limitation of neck mobility
Morbid obesity (BMI ≥40 kg/m²)
Obstructive upper airway masses (e.g., head and neck tumors)
Prior neck radiotherapy
Clinically relevant neck masses
Major facial/mandibular trauma or craniofacial anomalies
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cohort 1: Adult patients undergoing surgery under general anesthesia
Adult patients (18-70 years, ASA I-III) scheduled for elective surgery under general anesthesia requiring orotracheal intubation.
Preoperative clinical airway assessment and ultrasonographic airway measurements were recorded, and intraoperative intubation and mask ventilation outcomes were evaluated
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants with Difficult Intubation
Time Frame: During induction of anesthesia (intraoperative)
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Difficult intubation was defined as requiring two or more intubation attempts (≥2 attempts) during induction of general anesthesia.
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During induction of anesthesia (intraoperative)
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Number of Participants with Difficult Mask Ventilation
Time Frame: During induction of anesthesia (intraoperative)
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Difficult mask ventilation was defined as the need for two-handed mask ventilation or inability to ventilate adequately using a face mask
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During induction of anesthesia (intraoperative)
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Collaborators and Investigators
Investigators
- Principal Investigator: Serkan Telli, MD, Kütahya Health Sciences University
Publications and helpful links
General Publications
- 1. Cook TM, MacDougall-Davis SR. Complications and failure of airway management. Br J Anaesth. 2012;109 Suppl 1(suppl 1):i68-i85. 2. Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, et al. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022;136(1):31-81. 3. Roth D, Pace NL, Lee A, Hovhannisyan K, Warenits AM, Arrich J, et al. Airway physical examination tests for detection of difficult airway management in apparently normal adult patients. Cochrane Database Syst Rev. 2018;5(5):CD008874. 4. Shiga T, Wajima Z, Inoue T, Sakamoto A. Predicting difficult intubation in apparently normal patients: a meta-analysis of bedside screening test performance. Anesthesiology. 2005;103(2):429-37. 5. Detsky ME, Jivraj N, Adhikari NK, Friedrich JO, Pinto R, Simel DL, et al. Will This Patient Be Difficult to Intubate?: The Rational Clinical Examination Systematic Review. JAMA. 2019;321(5):493-503. 6. Singh M, Chin KJ, Chan VW, Wong DT, Prasad GA, Yu E. Use of sonography for airway assessment: an observational study. J Ultrasound Med. 2010;29(1):79-85. 7. Kundra P, Mishra SK, Ramesh A. Ultrasound of the airway. Indian J Anaesth. 2011;55(5):456-62. 8. Marchis IF, Negrut MF, Blebea CM, Crihan M, Alexa AL, Breazu CM. Trends in Preoperative Airway Assessment. Diagnostics (Basel). 2024;14(6). 9. Yao W, Wang B. Can tongue thickness measured by ultrasonography predict difficult tracheal intubation? Br J Anaesth. 2017;118(4):601-9. 10. Daggupati H, Maurya I, Singh RD, Ravishankar M. Development of a scoring system for predicting difficult intubation using ultrasonography. Indian J Anaesth. 2020;64(3):187-92. 11. Sotoodehnia M, Khodayar M, Jalali A, Momeni M, Safaie A, Abdollahi A. Prediction of difficult laryngoscopy / difficult intubation cases using upper airway ultrasound measurements in emergency department: a prospective observational study. BMC Emerg Med. 2023;23(1):78
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 2023/10-19
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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