- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07384611
Preoperative Prediction of Difficult Airway in Children
February 10, 2026 updated by: Elif Sule Ozdemir, Diskapi Yildirim Beyazit Education and Research Hospital
Prediction of Difficult Airway in Pediatric Patients Using Preoperative Clinical Parameters
This prospective observational study aims to evaluate the predictive value of preoperative clinical airway assessment parameters for difficult airway management in pediatric patients undergoing elective surgery under general anesthesia.
Preoperative clinical measurements and bedside airway tests will be recorded, and their association with intraoperative airway outcomes, including difficult laryngoscopy and difficult intubation, will be analyzed.
Difficult laryngoscopy will be defined as Cormack-Lehane grade III-IV, while secondary outcomes will include difficult intubation, difficult mask ventilation, and airway-related complications.
The study seeks to identify clinically applicable predictors and improve preoperative risk stratification for pediatric airway management.
The findings may contribute to safer anesthetic practice in children by facilitating early identification of patients at increased airway risk.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1000
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
- Name: Elif Şule Özdemir Sezgi
- Phone Number: 00905059209638
- Email: elifsule-91@hotmail.com
Study Contact Backup
- Name: Aslı Dönmez
- Phone Number: 00905322256473
- Email: aslidonmez@hotmail.com
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06000
- Recruiting
- Ankara Etlik City Hospital
-
Contact:
- Elif Şule Özdemir Sezgi, M.D.
- Phone Number: 00905059209638
- Email: elifsule-91@hotmail.com
-
Contact:
- Aslı Dönmez, Professor
- Phone Number: 00905322256473
- Email: aslidonmez@hotmail.com
-
-
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
- Child
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
The study population consists of pediatric patients aged 0 to 12 years who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.
Description
Inclusion Criteria:
- Pediatric patients aged 0-12 years
- Scheduled for elective surgery requiring endotracheal intubation under general anesthesia
- ASA physical status I-III
- Written informed consent obtained from parent(s) or legal guardian(s)
Exclusion Criteria:
- Patients older than 12 years
- ASA physical status IV or higher
- Emergency situations that do not allow systematic documentation of the airway management process
- Presence of a congenital or acquired tracheostomy
- Surgical procedures planned to be performed using a supraglottic airway without endotracheal intubation
- Surgical procedures planned to be performed using face mask ventilation without endotracheal intubation
- Inability to obtain parental or legal guardian consent
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difficult Laryngoscopy
Time Frame: Perioperative/Periprocedural
|
Difficult laryngoscopy defined as Cormack-Lehane grade III or IV during laryngoscopy at tracheal intubation.
|
Perioperative/Periprocedural
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First-Attempt Intubation Success
Time Frame: Perioperative/Periprocedural
|
Successful tracheal intubation achieved on the first attempt without the need for additional airway devices or techniques.
|
Perioperative/Periprocedural
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 2, 2026
Primary Completion (Estimated)
May 3, 2027
Study Completion (Estimated)
May 20, 2027
Study Registration Dates
First Submitted
January 18, 2026
First Submitted That Met QC Criteria
January 29, 2026
First Posted (Actual)
February 3, 2026
Study Record Updates
Last Update Posted (Actual)
February 11, 2026
Last Update Submitted That Met QC Criteria
February 10, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- AEŞH-EK-2026-009
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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