NCT07141485

Brief Summary

This prospective observational study aims to compare the effectiveness of the Paediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC) and the Intubation Difficulty Scale (IDS) in evaluating difficult tracheal intubation in pediatric patients aged 0 to 5 years. Patients undergoing general anesthesia with videolaryngoscopic intubation will be assessed using both scoring systems. The study seeks to determine which system more accurately reflects the difficulty of intubation and serves as a better guide for future anesthetic management, ultimately contributing to improved patient safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 28, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

March 18, 2026

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 19, 2025

Last Update Submit

March 17, 2026

Conditions

Keywords

Pediatric intubationDifficult airwayPeDiACIntubation Difficulty Scale (IDS)VideolaryngoscopyModified Cormack-Lehane classificationPediatric anesthesiaTracheal intubation

Outcome Measures

Primary Outcomes (1)

  • Comparison of PeDiAC Score and IDS Score for Predicting Difficult Intubation in Children Aged 0-5 Years

    This outcome measure evaluates the effectiveness of two scoring systems-PeDiAC and Intubation Difficulty Scale (IDS)-in reflecting the difficulty of tracheal intubation in pediatric patients aged 0 to 5 years. Both scores will be calculated for each patient immediately after intubation. The correlation between each score and the actual intubation experience will be statistically analyzed to determine which scoring system better predicts intubation difficulty.

    Immediately after tracheal intubation

Study Arms (1)

Pediatric Patients Undergoing Videolaryngoscopic Intubation

This group includes pediatric patients aged 0-5 years undergoing elective or emergency surgery under general anesthesia with videolaryngoscopic intubation. All patients will be evaluated for intubation difficulty using both the PeDiAC and the Intubation Difficulty Scale (IDS).

Eligibility Criteria

Age0 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study will enroll pediatric patients aged 0 to 5 years who are undergoing general anesthesia for elective and emergent surgical procedures requiring tracheal intubation. Patients will be intubated using a videolaryngoscope. Subjects with difficult airway history, emergency surgery, or airway pathology will be excluded. The study aims to compare two scoring systems evaluating intubation difficulty in this age group.

You may qualify if:

  • Pediatric patients between 0 and 5 years of age
  • Undergoing general anesthesia for any type of surgical procedure
  • ASA physical status classification I to IV
  • Written informed consent obtained from parents or legal guardians

You may not qualify if:

  • Patients undergoing awake fiberoptic intubation
  • History of tracheal resection or reconstruction surgery
  • Refusal to participate or absence of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital, Department Of Anesthesiology and Reanimation

Ankara, Turkiye, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 26, 2025

Study Start

August 28, 2025

Primary Completion

January 20, 2026

Study Completion

January 30, 2026

Last Updated

March 18, 2026

Record last verified: 2025-08

Locations