Clinical trial NCT05833347: Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients
Official title: Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation; Difficult or Failed
Difficult Laryngoscopy
Keywords: Difficult laryngoscopy
Ultrasonography
Pediatric Airway
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 121
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difficult laryngoscopy
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi University
state: Eskisehir
Study officials:
affiliation: Eskisehir Osmangazi University
name: Osman Kaya, Res Assist.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.