Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatrics

Difficult Airway Clinical Trial

Official title:

Evaluation of Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05336474
• Other study ID #: 2020/132
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2023
• Source: Istanbul University
• Contact: Demet Altun
• Phone: 00905326811767
• Email: drdemetaltun[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: September 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficult Airway

Intervention

Diagnostic Test:
• Ultrasonographic upper airway measurements
Ultrasonographic upper airway measurements: Epiglottis-skin distance, Hyoid bone-skin distance, Anterior commissure-skin distance and Thickness of tounge

Locations

Country	Name	City	State
Turkey	Istanbul University, Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cormack-Lehane Classification	he anesthesiologist, who is blind to the patient's preoperative airway evaluation and ultrasonographic airway measurements, performs intubation and evaluates the laryngeal view.	Three minutes after induction of anesthesia.
Primary	Epiglottis skin distance in centimeters.	The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures hyoid bone to skin distance.	Five minutes before induction of anesthesia.
Primary	Hyoid bone-skin distance in centimeters.	The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures hyoid bone to skin distance.	Five minutes before induction of anesthesia.
Primary	Anterior commissure-skin distance in centimeters.	The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures anterior commissure to skin distance.	Five minutes before induction of anesthesia
Primary	Thickness of tongue root in centimeters	The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures thickness of tongue root.	Five minutes before induction of anesthesia
Secondary	intubation difficulty score (IDS )(between 0 to 7)	The anesthesiologist, who performed the intubation, evaluated the intubation difficulty.	During the intubation period
Secondary	Mallampati classification	Evaluated by the anesthesiologist who performs intubation.	The day before surgery
Secondary	Neck circumference in centimeters.	Evaluated by the anesthesiologist who performs intubation.	The day before surgery
Secondary	Sternomental distance in centimeters.	The distance between sternal notch and mentum. Evaluated by the anesthesiologist who performs intubation.	The day before surgery
Secondary	Thyromental distance in centimeters	The distance between thyroid notch and mentum. Evaluated by the anesthesiologist who performs intubation.	The day before surgery
Secondary	Body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2.Evaluated by the anesthesiologist who performs intubation.	The day before surgery
Secondary	intubation techniques	techniques consisting of classic laryngoscope, videolaryngoscope, stylet, and supraglottic airway device used in intubation	During the intubation period