Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatrics

Sponsor
Istanbul University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05336474
Collaborator
(none)
200
1
4.5
44.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasonographic upper airway measurements

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatric Patients
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 15, 2022

Outcome Measures

Primary Outcome Measures

  1. Cormack-Lehane Classification [Three minutes after induction of anesthesia.]

    he anesthesiologist, who is blind to the patient's preoperative airway evaluation and ultrasonographic airway measurements, performs intubation and evaluates the laryngeal view.

  2. Epiglottis skin distance in centimeters. [Five minutes before induction of anesthesia.]

    The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures hyoid bone to skin distance.

  3. Hyoid bone-skin distance in centimeters. [Five minutes before induction of anesthesia.]

    The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures hyoid bone to skin distance.

  4. Anterior commissure-skin distance in centimeters. [Five minutes before induction of anesthesia]

    The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures anterior commissure to skin distance.

  5. Thickness of tongue root in centimeters [Five minutes before induction of anesthesia]

    The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures thickness of tongue root.

Secondary Outcome Measures

  1. intubation difficulty score (IDS )(between 0 to 7) [During the intubation period]

    The anesthesiologist, who performed the intubation, evaluated the intubation difficulty.

  2. Mallampati classification [The day before surgery]

    Evaluated by the anesthesiologist who performs intubation.

  3. Neck circumference in centimeters. [The day before surgery]

    Evaluated by the anesthesiologist who performs intubation.

  4. Sternomental distance in centimeters. [The day before surgery]

    The distance between sternal notch and mentum. Evaluated by the anesthesiologist who performs intubation.

  5. Thyromental distance in centimeters [The day before surgery]

    The distance between thyroid notch and mentum. Evaluated by the anesthesiologist who performs intubation.

  6. Body mass index (BMI) [The day before surgery]

    Weight and height will be combined to report BMI in kg/m^2.Evaluated by the anesthesiologist who performs intubation.

  7. intubation techniques [During the intubation period]

    techniques consisting of classic laryngoscope, videolaryngoscope, stylet, and supraglottic airway device used in intubation

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University, Istanbul Faculty of Medicine Istanbul Turkey

Sponsors and Collaborators

  • Istanbul University

Investigators

  • Principal Investigator: Demet Altun, Istanbul University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Demet Altun, Ass. prof., Istanbul University
ClinicalTrials.gov Identifier:
NCT05336474
Other Study ID Numbers:
  • 2020/132
First Posted:
Apr 20, 2022
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Demet Altun, Ass. prof., Istanbul University

Study Results

No Results Posted as of Aug 2, 2022