Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients

NCT05833347 | Completed

• 1 other identifier: ESOGU-OKAYA-001
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation; Difficult or Failed; Difficult Laryngoscopy

Keywords

Difficult laryngoscopy; Ultrasonography; Pediatric Airway

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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); Diagnostic Test: Distance between Skin-Vocal Cord Anterior Commissura(DSAC); Diagnostic Test: Distance between Skin-Epiglottic(DSE)

Interventions

Distance between Skin-Hyoid Bone(DSHB) DIAGNOSTIC_TEST

Hyoid bone-skin distance Other Name: DSHB

2-8 Years Paediatric Patients

Distance between Skin-Vocal Cord Anterior Commissura(DSAC) DIAGNOSTIC_TEST

Vocal cord anterior commissura-skin distance Other Name: DSAC

2-8 Years Paediatric Patients

Distance between Skin-Epiglottic(DSE) DIAGNOSTIC_TEST

Skin-epiglottic distance Other Name: DSE

2-8 Years Paediatric Patients

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Eskişehir, 26040, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 25403231 BACKGROUND

• 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.

  PMID: 31742568 BACKGROUND

• 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.

  PMID: 32730647 BACKGROUND

Study Officials

• Osman Kaya, Res Assist.

  Eskisehir Osmangazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 27, 2023
• Study Start: May 10, 2023
• Primary Completion: December 15, 2023
• Study Completion: January 4, 2024
• Last Updated: February 16, 2024

Record last verified: 2023-11

Locations

TU (1)