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Enrolling by Invitation

NCT Number: NCT07185516

Airway Ultrasound Indices for Prediction of Difficult Laryngoscopy in Pediatric Patients

The goal of this observational study is to compare the airway ultrasound indices and the preoperative clinical airway assessment concerning the difficult laryngoscopic view in paediatric patients undergoing elective surgery under general anaesthesia

The main question it aims to answer is:

• Do airway ultrasound indices better predict difficult laryngoscopic view in paediatric patients than clinical airway assessment?

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, 69711, Egypt

About this study

Airway-related morbidity, as a result of an inability to anticipate a difficult airway, remains the primary concern for an anesthesiologist. Various clinical measurements and methods, such as the thyromental distance (TMD), sternomental distance, horizontal length of the mandible, head and neck movement, and the Mallampati score, were used to predict difficult laryngoscopy and intubation in adult patients. However, using these measurements in the pediatric population is not as easy as in adults.

The use of airway sonography has been extended as an assessment tool for a difficult airway. Various parameters like tongue thickness, anterior soft tissue thickness, and hyomental distance ratio have been used to predict a difficult airway. However, the usefulness of ultrasonography to predict a difficult airway in infants and children has still not been described. This study will compare the effectiveness of clinical measurements to the ultrasound indices in predicting difficult laryngoscopic view in paediatric patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA Class I and II.
  • Patients undergoing elective surgery under general anaesthesia

Exclusion criteria

  • Congenital upper airway malformation.
  • Head and neck swellings.
  • Scars.
  • Radiation to the neck.
  • Tracheotomy.
  • Neurosurgical or cardiac procedures.
  • ENT surgeries.

Treatment and study plan

Airway ultrasound indices

Other

Tongue thickness, hyomental distance in neutral position (HMDRn), hyomental distance in extended position (HMDRe), ratio of hyomental distance in both positions (HMDR), thyromental distance (TMD), ratio of tongue thickness to thyromental distance (TT/TMD), epiglottis thickness &pre-epiglottic space thickness

Clinical airway assessment

Other

Mallampati grading and thyromental distance (TMD). The glottic structures displayed during laryngoscopy will be classified according to the Cormack-Lehane

Primary outcomes

  1. Prevalence rate of difficult intubation

    Time frame: 60 Seconds

    failure to intubate the patient within 60 seconds

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Airway Ultrasound Indices Versus Clinical Assessment for Prediction of Difficult Laryngoscopy in Elective Surgical Pediatric Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.