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.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult or Failed; Difficult Laryngoscopy
• Intervention / Treatment: Diagnostic test: Distance between Skin-Hyoid Bone(DSHB); Diagnostic test: Distance between Skin-Vocal Cord Anterior Commissura(DSAC); Diagnostic test: Distance between Skin-Epiglottic(DSE)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• Turkey
  • Eskisehir
    • Eskişehir, Eskisehir, Turkey, 26040
      • Eskisehir Osmangazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

A hundred twenty patients, aged 2-8 years-old, with an American Anesthesiology Association physical classification (ASA) I-III planned to undergo general anesthesia for elective surgery, will be included in the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

2-8 Years Paediatric Patients; 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.

Diagnostic test: Distance between Skin-Hyoid Bone(DSHB); Hyoid bone-skin distance Other Name: DSHB; Diagnostic test: Distance between Skin-Vocal Cord Anterior Commissura(DSAC); Vocal cord anterior commissura-skin distance Other Name: DSAC; Diagnostic test: Distance between Skin-Epiglottic(DSE); Skin-epiglottic distance Other Name: DSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficult laryngoscopy	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.	1 minute

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Investigators: Principal Investigator: Osman Kaya, Res Assist., Eskisehir Osmangazi University

Publications and helpful links

General Publications

• Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.
• 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.
• Altun D, Kara H, Bozbora E, Ali A, Dinc T, Sonmez S, Buget M, Aydemir L, Basaran B, Tugrul M, Camci E. The Role of Indirect Laryngoscopy, Clinical and Ultrasonographic Assessment in Prediction of Difficult Airway. Laryngoscope. 2021 Feb;131(2):E555-E560. doi: 10.1002/lary.28849. Epub 2020 Jul 30.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasonography; Difficult laryngoscopy; Pediatric Airway
• Other Study ID Numbers: ESOGU-OKAYA-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No