NCT07384611

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress20%
Feb 2026May 2027

First Submitted

Initial submission to the registry

January 18, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2027

Expected
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2027

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

January 18, 2026

Last Update Submit

February 10, 2026

Conditions

Keywords

Pediatric AnesthesiaDifficult LaryngoscopyDifficult Airway

Outcome Measures

Primary Outcomes (1)

  • Difficult Laryngoscopy

    Difficult laryngoscopy defined as Cormack-Lehane grade III or IV during laryngoscopy at tracheal intubation.

    Perioperative/Periprocedural

Secondary Outcomes (1)

  • First-Attempt Intubation Success

    Perioperative/Periprocedural

Interventions

Preoperative clinical airway assessment including bedside airway examination and anthropometric measurements performed as part of routine anesthetic evaluation, without any additional intervention beyond standard clinical practice.

Eligibility Criteria

Age1 Day - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06000, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Elif Şule Özdemir Sezgi

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

January 18, 2026

First Posted

February 3, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

May 3, 2027

Study Completion (Estimated)

May 20, 2027

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations