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Not yet recruiting NCT06892405

Airway US in Predicting Difficult Pediatric Laryngoscopy

— Observational Airway Complication of Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SonoSite™ S Series ultrasound.
Who it may be relevant to
Registry conditions: Airway Complication of Anesthesia. Basic parameters: 2 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Using Ultrasound to Predict the Difficulty of Direct Laryngoscopy in Pediatrics.

Overview

The hypothesis of this study is that ultrasound measurements may improve the preoperative detection of difficult laryngoscopy (DL) in pediatrics. The primary objective of this study will be to evaluate the usefulness for the prediction of a DL of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Secondary objectives will include establishing, if possible, a cut-off point in these measurements; to compare these measures against the classic pre-intubation clinical screening tests.

Detailed description

Current advances in airway management training have reduced the risk associated with an unanticipated DL but have not been able to reduce its incidence in clinical practice. The addition of new video laryngoscopes in our clinical practice seems to offer a paradigm shift to face a DL with promising results. However, theses authors also indicated that expertise in video laryngoscopy requires prolonged training and practice. Otherwise, a growing number of publications have showed that some ultrasound measurements may improve our anticipation of a DL because of its high accuracy to offer detailed anatomical images of the airway, absence of ionizing radiations, accessibility and reproducibility. Among all the ultrasound parameters studied, distance from skin to epiglottis with a cut-off point of 2.10 cm, showed the best predictive ability with a sensitivity of 83.33%3 and a specificity of 73.33%, for predicting difficulty in airway management in routine clinical practice. The aim of this study is to investigate the efficacy of US-measured airway structures in predicting difficult laryngoscopy (defined as CL grade III and IV).

Interventions

  • Device SonoSite™ S Series ultrasound
    US measurements will be performed in the pre-operating room a , patients are placed in supine position with the head in a sniffing position on a surgical pillow and using the 15 MHz linear array transducer of the SonoSite™ S Series ultrasound in transverse position. A scan is made from the skin surface of the floor of the mouth to the trachea exerting the minimum possible pressure to identify the structures correctly.

Primary outcome measures

  • prediction of a Difficult laryngoscopy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). [Time frame: Preoperative]
Secondary outcome measures (3)
  • The Modified Mallampati Score (MMS). [Time frame: At Intubation]
  • The thyromental distance (TMD) [Time frame: preoperative]
  • The upper lip bite test (ULBT) [Time frame: Preoperative]

Eligibility criteria

Inclusion criteria

  • Gender both males and females
  • ASA Class I and II
  • Age 2 years to 6
  • Children scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.

Exclusion criteria

  • Congenital upper airway malformation,
  • Head and neck swellings,
  • Scars,
  • Radiation to the neck,
  • Tracheotomy,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Assiut university Pediatric hospital — Asyut

Identifiers

NCT: NCT06892405 · 04-2024-201007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗