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

NCT ID: NCT07141485

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

406 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-22

Study Completion Date

2026-01-30

Brief Summary

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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

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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

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Videolaryngoscopy Difficult Airway, Videolaryngoscopes Airway Management Assessment Pediatric Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patients undergoing awake fiberoptic intubation
* History of tracheal resection or reconstruction surgery
* Refusal to participate or absence of informed consent
Minimum Eligible Age

0 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ankara Bilkent City Hospital, Department Of Anesthesiology and Reanimation

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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ŞENGÜL ÖZMERT, Assoc. Prof. MD

Role: CONTACT

+905323861201

GÖZDE İREM DEMİRCİ GÖKÇE, Resident Doctor

Role: CONTACT

+905302488966

Other Identifiers

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PEDIAC-VL-2025-GID

Identifier Type: -

Identifier Source: org_study_id

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