Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients

Pediatric patients pose challenges in airway management due to anatomical and physiological changes. Using recommended predictive tests for predicting difficult airway can be improved by combining them with ultrasound measurement of the anterior soft tissues of the neck. In this study, the investigators aim to evaluate the ultrasound measurement of anterior neck soft tissues in paediatric patients before anesthesia induction, to anticipate difficult laryngoscopy.

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Key information

Conditions

Intubation; Difficult or Failed Difficult Laryngoscopy

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eskisehir Osmangazi University

Eskişehir, 26040, Turkey (Türkiye)

About this study

Eligible participants for this study will be patients aged 2-8 years scheduled for elective surgery under general anesthesia who have provided informed consent. During the preoperative evaluation, demographic data and airway physical examination results (Mallampati score) of the patients will be recorded. Patients who have received preoperative sedation will be positioned supine on the operating table, and ultrasound-guided measurements of soft tissue distances will be taken using a linear probe with a frequency range of 6-13 Hz. The distance between the hyoid bone and skin (DSHB), distance between the vocal cord anterior commissure and skin (DSAC), and distance between the epiglottis and skin (DSE) will be measured. The A/E (Anterior Commissura/Epiglottis) ratio will be calculated after measurements.

After standard monitoring and anesthesia induction, difficult laryngoscopy will be evaluated using the Modified Cormack Lehane Score, which grades the visibility of vocal cords and glottic structures. A grade of 3 or 4 on this scale will be considered as difficult laryngoscopy and recorded as such. Tracheal intubation will be performed by an anesthesiologist with at least two years of experience who is unaware of the ultrasound measurements.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients planned to undergo general anesthesia for elective surgery
American Anesthesiology Association physical classification (ASA) status I-III
Body mass index (BMI) above 30

Exclusion criteria

Patients with a history of difficult airway or with conditions that are known to be associated with a difficult airway, such as syndromic or metabolic diseases.
Patients with congenital maxillofacial defects.
Patients with tracheal or laryngeal pathology.
Patients with pulmonary diseases such as bronchial asthma or airway hyperreactivity.
Patients with allergies to ultrasound gel.
Patients with weight percentile outside the range of 10-90 percentiles.
Patients undergoing emergency surgery.

Treatment and study plan

Distance between Skin-Hyoid Bone(DSHB)

Diagnostic Test

Hyoid bone-skin distance Other Name: DSHB

Distance between Skin-Vocal Cord Anterior Commissura(DSAC)

Diagnostic Test

Vocal cord anterior commissura-skin distance Other Name: DSAC

Distance between Skin-Epiglottic(DSE)

Diagnostic Test

Skin-epiglottic distance Other Name: DSE

Primary outcomes

Difficult laryngoscopy

Time frame: 1 minute

As the primary outcome, correlation of distance between the hyoid bone and skin (DSHB), distance between the vocal cord anterior commissure and skin (DSAC), and distance between the epiglottis and skin (DSE) and A/E (Anterior Commissura/Epiglottis) ratio with the Cormack Lehane score will be evaluated.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2024
First posted: Apr 27, 2023
Registry last updated: Feb 16, 2024

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.

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