NCT05336474

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

April 11, 2022

Last Update Submit

May 8, 2023

Conditions

Difficult Airway

Keywords

difficult airwaypediatric anesthesialaryngoscopy

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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

  • 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 Outcomes (7)

  • intubation difficulty score (IDS )(between 0 to 7)

    During the intubation period

  • Mallampati classification

    The day before surgery

  • Neck circumference in centimeters.

    The day before surgery

  • Sternomental distance in centimeters.

    The day before surgery

  • Thyromental distance in centimeters

    The day before surgery

  • +2 more secondary outcomes

Interventions

Ultrasonographic upper airway measurementsDIAGNOSTIC_TEST

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

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • Children, aged between 1-12 years
  • Children who required endotracheal intubation under general anesthesia for elective procedures
  • written informed parental consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 25437694BACKGROUND

Study Officials

  • Demet Altun

    Istanbul University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Demet Altun

CONTACT

00905326811767drdemetaltun@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. prof.

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 20, 2022

Study Start

April 1, 2022

Primary Completion

September 10, 2023

Study Completion

September 30, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

TU(1)