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Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatrics

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ClinicalTrials.gov Identifier: NCT05336474
Recruitment Status : Recruiting
First Posted : April 20, 2022
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Demet Altun, Istanbul University

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
Difficult Airway 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.

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Study Type : Observational
Estimated 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 : April 1, 2022
Actual Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 15, 2022

Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. intubation difficulty score (IDS )(between 0 to 7) [ Time Frame: During the intubation period ]
    The anesthesiologist, who performed the intubation, evaluated the intubation difficulty.

  2. Mallampati classification [ Time Frame: The day before surgery ]
    Evaluated by the anesthesiologist who performs intubation.

  3. Neck circumference in centimeters. [ Time Frame: The day before surgery ]
    Evaluated by the anesthesiologist who performs intubation.

  4. Sternomental distance in centimeters. [ Time Frame: The day before surgery ]
    The distance between sternal notch and mentum. Evaluated by the anesthesiologist who performs intubation.

  5. Thyromental distance in centimeters [ Time Frame: The day before surgery ]
    The distance between thyroid notch and mentum. Evaluated by the anesthesiologist who performs intubation.

  6. 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.

  7. intubation techniques [ Time Frame: During the intubation period ]
    techniques consisting of classic laryngoscope, videolaryngoscope, stylet, and supraglottic airway device used in intubation



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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05336474


Contacts
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Contact: Demet Altun 00905326811767 drdemetaltun@hotmail.com

Locations
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Turkey
Istanbul University, Istanbul Faculty of Medicine Recruiting
Istanbul, Turkey
Contact: Demet Altun    00905326811767    drdemetaltun@hotmail.com   
Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: Demet Altun Istanbul University
Publications:
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Responsible Party: Demet Altun, Ass. prof., Istanbul University
ClinicalTrials.gov Identifier: NCT05336474    
Other Study ID Numbers: 2020/132
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Demet Altun, Istanbul University:
difficult airway
pediatric anesthesia
laryngoscopy