Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatrics

May 8, 2023 updated by: Demet Altun, Istanbul University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Istanbul University, Istanbul Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cormack-Lehane Classification
Time Frame: 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.
Three minutes after induction of anesthesia.
Epiglottis skin distance in centimeters.
Time Frame: 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.
Five minutes before induction of anesthesia.
Hyoid bone-skin distance in centimeters.
Time Frame: 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.
Five minutes before induction of anesthesia.
Anterior commissure-skin distance in centimeters.
Time Frame: 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.
Five minutes before induction of anesthesia
Thickness of tongue root in centimeters
Time Frame: 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.
Five minutes before induction of anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation difficulty score (IDS )(between 0 to 7)
Time Frame: During the intubation period
The anesthesiologist, who performed the intubation, evaluated the intubation difficulty.
During the intubation period
Mallampati classification
Time Frame: The day before surgery
Evaluated by the anesthesiologist who performs intubation.
The day before surgery
Neck circumference in centimeters.
Time Frame: The day before surgery
Evaluated by the anesthesiologist who performs intubation.
The day before surgery
Sternomental distance in centimeters.
Time Frame: The day before surgery
The distance between sternal notch and mentum. Evaluated by the anesthesiologist who performs intubation.
The day before surgery
Thyromental distance in centimeters
Time Frame: The day before surgery
The distance between thyroid notch and mentum. Evaluated by the anesthesiologist who performs intubation.
The day before surgery
Body mass index (BMI)
Time Frame: The day before surgery
Weight and height will be combined to report BMI in kg/m^2.Evaluated by the anesthesiologist who performs intubation.
The day before surgery
intubation techniques
Time Frame: During the intubation period
techniques consisting of classic laryngoscope, videolaryngoscope, stylet, and supraglottic airway device used in intubation
During the intubation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Demet Altun, Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

September 10, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020/132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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