NCT07245511

Brief Summary

This prospective observational study aims to evaluate three scoring systems (VIDIAC (Video Laryngoscopic Intubation and Difficult Airway Classification), PeDiAC (Pediatric Difficult Airway Classification), and the Intubation Difficulty Scale (IDS)). A total of 450 children undergoing general anesthesia with videolaryngoscopic intubation will be included in the study. Demographic data, intraoperative parameters, and glottic imaging, as well as detailed intubation-related variables such as total intubation time, number of attempts, complications, and subjective intubation ease scores will be recorded.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

September 24, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

October 16, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

November 24, 2025

Status Verified

October 1, 2025

Enrollment Period

5 months

First QC Date

September 24, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

intubation difficulty scale (IDS)VIDIACPeDiACPediatric anesthesiavideolaryngoscopyairway management

Outcome Measures

Primary Outcomes (2)

  • Comparison of VIDIAC, PeDiAC, and IDS Scores in the Evaluation of Difficult Intubation in Children

    For each patient, VIDIAC, PeDiAC, and Intubation Difficulty Scale (IDS) scores will be calculated immediately after tracheal intubation via videolaryngoscopy. These scores will be statistically analyzed to determine the correlation between the number of intubation attempts, intubation time, complications, and subjective intubation ease ratings, in order to identify the scoring system that provides the most reliable assessment of difficult intubation in children.

    Immediately after tracheal intubation

  • A Prospective Observational Study Comparing VIDIAC, PeDiAC, and the Intubation Difficulty Scale (IDS) in Assessing Difficult Intubation in Pediatric Patients Aged 5-18 Years Undergoing Tracheal Intubation with Videolaryngoscopy

    For each patient, VIDIAC, PeDiAC, and Intubation Difficulty Scale (IDS) scores will be calculated immediately after tracheal intubation via videolaryngoscopy. These scores will be statistically analyzed to determine the correlation between the number of intubation attempts, intubation time, complications, and subjective intubation ease ratings, in order to identify the scoring system that provides the most reliable assessment of difficult intubation in children.

    Immediately after tracheal intubation

Study Arms (1)

Pediatric Patients Undergoing Videolaryngoscopic Intubation

This cohort will include pediatric patients aged 5 to 18 years undergoing elective or emergency surgery under general anesthesia who require tracheal intubation. All patients will be intubated using a C-MAC videolaryngoscope. Each intubation will be evaluated using the VIDIAC, PeDiAC, and Intubation Difficulty Scale (IDS) scoring systems.

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study will include pediatric patients aged 5 to 18 years who are scheduled for elective or emergency surgery under general anesthesia at Ankara Bilkent City Hospital. All participants will require tracheal intubation performed with a C-MAC videolaryngoscope. Eligible patients will have an ASA physical status classification of I-IV. Written informed consent will be obtained from parents or legal guardians prior to enrollment. Patients undergoing awake fiberoptic intubation, those with a history of tracheal resection, or children younger than 5 years will be excluded.

You may qualify if:

  • Pediatric patients between 5 and 18 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)

RECRUITING

Central Study Contacts

SENGÜL ÖZMERT, Assoc. Prof. MD

CONTACT

GÖZDE İREM DEMİRCİ GÖKÇE, Resident Doctor

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 24, 2025

First Posted

November 24, 2025

Study Start

October 16, 2025

Primary Completion

March 15, 2026

Study Completion

April 15, 2026

Last Updated

November 24, 2025

Record last verified: 2025-10

Locations