- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07141485
- Original Trial
Comparison of PeDiAC and the Intubation Difficulty Scale in Pediatric Patients Intubated With Videolaryngoscopy (VIDEOPED)
Comparison of the PeDiAC Score and Intubation Difficulty Scale in Pediatric Patients Aged 0-5 Years Undergoing Tracheal Intubation With Videolaryngoscopy
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Turkiye
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Ankara, Turkiye, Turkey (Türkiye)
- Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Eligible participants will be pediatric patients aged 0 to 5 years who are undergoing general anesthesia for any surgical procedure. All included patients must undergo tracheal intubation using a videolaryngoscope (C-MAC). Patients must have an ASA physical status classification of I to IV and written informed consent must be obtained from a parent or legal guardian prior to participation.
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of PeDiAC Score and IDS Score for Predicting Difficult Intubation in Children Aged 0-5 Years
Time Frame: Immediately after tracheal intubation
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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.
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Immediately after tracheal intubation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PEDIAC-VL-2025-GID
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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