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Clinical Trials/NCT05833347
NCT05833347CompletedNot Applicable

Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients

Eskisehir Osmangazi University1 site in 1 country121 target enrollmentStarted: May 10, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
121
Locations
1
Primary Endpoint
Difficult laryngoscopy

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to 8 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Eskisehir Osmangazi University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Osman Kaya

Trainee

Eskisehir Osmangazi University

Study Sites (1)

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