Clinical trial NCT05336474: Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatrics
Official title: Evaluation of Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Difficult Airway
Keywords: difficult airway
pediatric anesthesia
laryngoscopy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients, aged between 1-12 years, who required endotracheal intubation under general anesthesia for elective procedures were included in the study.

Brief summary: This study was designed to assess the accuracy of ultrasonographic parameters in combination to clinical parameters in the prediction of difficult airway in pediatric population.

All patients underwent a standard airway examination and sonographic airway assessment preoperatively and the predictive values for difficult airway of these methods were recorded.

Detailed description: Difficult airway in a pediatric patient is associated with more stresful situation than adults. Therefore, various clinical airways parameters have been investigated in the prediction of difficult airway. Sonographic evaluation to predict difficult airway is still primitive especially in pediatrics.

Ultrasonography and clinical parameters have been shown to be used in predicting difficult airway, but there is no study showing which is a better predictor.

Eligibility criteria: Inclusion Criteria:

* Children, aged between 1-12 years
* Children who required endotracheal intubation under general anesthesia for elective procedures
* written informed parental consent

Exclusion Criteria:

* children over the age of 12
* restrictive neck movement
* tracheostomized patient
* previous laryngeal surgery leading deformation of the laryngeal anatomy

Primary outcomes:
measure: Cormack-Lehane Classification
timeFrame: Three minutes after induction of anesthesia.
measure: Epiglottis skin distance in centimeters.
timeFrame: Five minutes before induction of anesthesia.
measure: Hyoid bone-skin distance in centimeters.
timeFrame: Five minutes before induction of anesthesia.
measure: Anterior commissure-skin distance in centimeters.
timeFrame: Five minutes before induction of anesthesia
measure: Thickness of tongue root in centimeters
timeFrame: Five minutes before induction of anesthesia
Secondary outcomes:
measure: intubation difficulty score (IDS )(between 0 to 7)
timeFrame: During the intubation period
measure: Mallampati classification
timeFrame: The day before surgery
measure: Neck circumference in centimeters.
timeFrame: The day before surgery
measure: Sternomental distance in centimeters.
timeFrame: The day before surgery
measure: Thyromental distance in centimeters
timeFrame: The day before surgery
measure: Body mass index (BMI)
timeFrame: The day before surgery
measure: intubation techniques
timeFrame: During the intubation period
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine
Study officials:
affiliation: Istanbul University
name: Demet Altun
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inal MT, Memis D, Sahin SH, Gunday I. [Comparison of different tests to determine difficult intubation in pediatric patients]. Rev Bras Anestesiol. 2014 Nov-Dec;64(6):391-4. doi: 10.1016/j.bjan.2014.02.001. Epub 2014 Aug 28. Portuguese.