- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07694167
Airway Ultrasound and PeDiAC Score in Pediatric Patients
Evaluation of the Relationship Between Ultrasonographic Airway Measurements and the PeDiAC Score in Pediatric Patients: A Prospective Observational Study
Study Overview
Status
Detailed Description
Difficult airway management in pediatric patients remains a significant challenge for anesthesiologists and is associated with increased perioperative morbidity. Accurate preoperative identification of children at risk for difficult airway management is essential for improving patient safety and optimizing airway strategies.
Airway ultrasonography has emerged as a noninvasive and bedside imaging modality that allows detailed assessment of upper airway anatomy. Several ultrasonographic airway parameters have been investigated as potential predictors of difficult airway management in children. However, the predictive value of these measurements remains uncertain, and their relationship with standardized pediatric difficult airway assessment tools has not been fully established.
The Pediatric Difficult Airway Classification (PeDiAC) score is a recently developed tool designed to standardize the assessment of difficult airway characteristics in pediatric patients. Evaluating the association between ultrasonographic airway measurements and the PeDiAC score may improve preoperative airway assessment and facilitate the identification of children at increased risk of difficult airway management.
This prospective observational study aims to investigate the relationship between preoperative ultrasonographic airway measurements and the PeDiAC score in pediatric patients undergoing elective surgery under general anesthesia. Preoperative airway ultrasound measurements will be obtained and compared with PeDiAC scores recorded during airway management.
The primary objective is to evaluate the correlation between ultrasonographic airway measurements and the PeDiAC score. Secondary objectives include assessing the predictive value of ultrasonographic measurements for difficult airway management and identifying airway parameters associated with increased airway difficulty in pediatric patients.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hatice Selçuk Kuşderci
- Phone Number: 505 215 98 96
- Email: drkusderci@hotmail.com
Study Contact Backup
- Name: Betül Ç Çiftçi Kurt
- Phone Number: 5301785995
- Email: betulciftcikurt@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged 1-18 years.
- Patients scheduled for elective surgery.
- Patients undergoing endotracheal intubation under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
Exclusion Criteria:
- Known craniofacial anomalies.
- Congenital airway malformations.
- Restricted cervical mobility.
- Emergency surgical procedures.
- Patients with a tracheostomy.
- Inability to obtain parental or legal guardian consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation Between Ultrasonographic Airway Measurements and the PeDiAC Score
Time Frame: During airway assessment and endotracheal intubation
|
Assessment of the correlation between preoperative ultrasonographic airway measurements and the Pediatric Difficult Airway Classification (PeDiAC) score.
|
During airway assessment and endotracheal intubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Predictive Value of Ultrasonographic Airway Measurements for Difficult Videolaryngoscopy
Time Frame: During videolaryngoscopy
|
Evaluation of the predictive ability of preoperative ultrasonographic airway measurements for difficult videolaryngoscopy in pediatric patients.
|
During videolaryngoscopy
|
|
Relationship Between the PeDiAC Score and Cormack-Lehane Grade
Time Frame: During videolaryngoscopy
|
Assessment of the association between the PeDiAC score and the Cormack-Lehane grade obtained during videolaryngoscopy.
|
During videolaryngoscopy
|
|
Relationship Between Intubation Time and Ultrasonographic Airway Measurements
Time Frame: During endotracheal intubation
|
Assessment of the association between intubation time and preoperative ultrasonographic airway measurements.
|
During endotracheal intubation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GOKAEK 2026/10/6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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