Clinical Trials Directory

Trials / Completed

CompletedNCT07141485

Comparison of PeDiAC and the Intubation Difficulty Scale in Pediatric Patients Intubated With Videolaryngoscopy

Comparison of the PeDiAC Score and Intubation Difficulty Scale in Pediatric Patients Aged 0-5 Years Undergoing Tracheal Intubation With Videolaryngoscopy

Status
Completed
Phase
Study type
Observational
Enrollment
430 (actual)
Sponsor
Ankara City Hospital Bilkent · Academic / Other
Sex
All
Age
0 Years – 5 Years
Healthy volunteers
Not accepted

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.

Detailed description

This prospective observational study aims to compare the effectiveness of two scoring systems-Paediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC) and the Intubation Difficulty Scale (IDS)-in assessing the difficulty of tracheal intubation in pediatric patients aged 0 to 5 years. Pediatric patients undergoing elective or emergency surgery under general anesthesia will be included in the study. All intubations will be performed using a C-MAC videolaryngoscope. Demographic data such as age, sex, weight, height, ASA physical status, and comorbidities will be recorded. Intraoperative monitoring parameters including peripheral oxygen saturation (SpO₂) and heart rate will also be documented. During intubation, the glottic view will be graded according to the Modified Cormack-Lehane classification. Additional variables-including the time required to achieve optimal glottic visualization, total intubation time (from insertion of the device to cuff inflation), number of intubation attempts, and any complications (e.g., desaturation, mucosal bleeding)-will be noted. Following intubation, both the intubating anesthesiologist and an independent observer will assign a subjective difficulty score using a visual analog scale ranging from 0 (extremely easy) to 10 (impossible). Subsequently, PeDiAC and IDS scores will be calculated for each case. The primary objective is to determine which of the two scoring systems more accurately reflects the actual difficulty of tracheal intubation in this age group and to identify the one that may better guide future airway management strategies-ultimately aiming to improve safety and clinical outcomes in pediatric anesthesia.

Conditions

Timeline

Start date
2025-08-28
Primary completion
2026-01-20
Completion
2026-01-30
First posted
2025-08-26
Last updated
2026-03-18

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07141485. Inclusion in this directory is not an endorsement.