CClinicalTrials.gg
RecruitingNCT05336474Updated May 9, 2023

Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatrics

An observational study in Difficult Airway, sponsored by Istanbul University. Recruiting at 1 site in Turkey. Open to participants aged 1 Year to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by Istanbul University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Apr 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
1 Year to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Difficult Airway

Keywords

  • difficult airway
  • pediatric anesthesia
  • laryngoscopy
03

In context

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 12 Years
Sexes eligible
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.

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

Exclusion Criteria:

  • children over the age of 12
  • restrictive neck movement
  • tracheostomized patient
  • previous laryngeal surgery leading deformation of the laryngeal anatomy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testUltrasonographic upper airway measurements

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Three minutes after induction of anesthesia.

  2. 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.

    Time frame: Five minutes before induction of anesthesia.

  3. 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.

    Time frame: Five minutes before induction of anesthesia.

  4. 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.

    Time frame: Five minutes before induction of anesthesia

  5. 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.

    Time frame: Five minutes before induction of anesthesia

Secondary outcomes

  1. intubation difficulty score (IDS )(between 0 to 7)

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

    Time frame: During the intubation period

  2. Mallampati classification

    Evaluated by the anesthesiologist who performs intubation.

    Time frame: The day before surgery

  3. Neck circumference in centimeters.

    Evaluated by the anesthesiologist who performs intubation.

    Time frame: The day before surgery

  4. Sternomental distance in centimeters.

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

    Time frame: The day before surgery

  5. Thyromental distance in centimeters

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

    Time frame: The day before surgery

  6. Body mass index (BMI)

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

    Time frame: The day before surgery

  7. intubation techniques

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

    Time frame: During the intubation period

07

Study locations

1 of 1 sites recruiting
  • Istanbul University, Istanbul Faculty of Medicine
    Istanbul, Turkey
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25437694 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05336474
Lead sponsor
Istanbul University
Responsible party
Demet Altun (Ass. prof., Istanbul University) — Principal investigator
First posted
Apr 20, 2022
Start date
Apr 1, 2022
Primary completion
Sep 10, 2023 (estimated)
Completion
Sep 30, 2023 (estimated)
Last update
May 9, 2023

Study contacts

Demet Altun
Contact
drdemetaltun@hotmail.com
00905326811767
Demet Altun
principal investigator · Istanbul University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion