Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients

Intubation; Difficult or Failed Clinical Trial

Official title:

Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05833347
• Other study ID #: ESOGU-OKAYA-001
• Status: Completed
• Start date: May 10, 2023
• Est. completion date: January 4, 2024

Study information

• Verified date: November 2023
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 4, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Difficult Laryngoscopy
• Intubation; Difficult or Failed

Intervention

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

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University	Eskisehir	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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