- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07245511
Comparison of VIDIAC, PeDiAC and Intubation Difficulty Scale in Pediatric Patients Undergoing Videolaryngoscopic Intubation (VIDIPEDIDS)
A Prospective Observational Study Comparing the VIDIAC, PeDiAC, and Intubation Difficulty Scale (IDS) in Pediatric Patients Aged 5-18 Years Undergoing Tracheal Intubation With Videolaryngoscopy
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.
Study Overview
Status
Detailed Description
This study is a prospective, observational, single-center study designed to compare three difficult intubation scales (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 elective or emergency surgery under general anesthesia at Ankara Bilkent City Hospital will be included in the study. All tracheal intubations will be performed using a C-MAC videolaryngoscope with an endotracheal tube appropriate for the child's age, weight, and surgical indication. No procedures beyond routine clinical practice will be performed, and informed consent will be obtained from parents or legal guardians prior to inclusion in the study.
Data collection will include demographic characteristics (age, gender, weight, height, ASA classification, comorbidities), intraoperative parameters (SpO₂, heart rate), and intubation-related variables: Glottic view graded using the modified Cormack-Lehane classification, time required for glottic visualization, total intubation time, number of attempts, use of adjuncts (stylet, bougie, alternative tubes), complications (desaturation, esophageal intubation, mucosal bleeding, tooth or lip trauma).
This study will evaluate difficult tracheal intubation in pediatric patients aged 5 to 18 years. Three difficult intubations The difficulty of intubation will be rated subjectively (0 = extremely easy, 10 = impossible) by the anesthesiologist performing the intubation and independently by an observer.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: SENGÜL ÖZMERT, Assoc. Prof. MD
- Phone Number: +905323861201
- Email: sengulozmert@yahoo.com.tr
Study Contact Backup
- Name: GÖZDE İREM DEMİRCİ GÖKÇE, Resident Doctor
- Phone Number: +905302488966
- Email: iremdemirci01@gmail.com
Study Locations
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Turkiye
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Ankara, Turkiye, Turkey (Türkiye)
- Recruiting
- Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation
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Contact:
- GOZDE IREM DEMIRCI GOKCE
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Eligible participants will be pediatric patients aged 5 to 18 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 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
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 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of VIDIAC, PeDiAC, and IDS Scores in the Evaluation of Difficult Intubation in Children
Time Frame: Immediately after tracheal intubation
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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.
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Immediately after tracheal intubation
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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
Time Frame: Immediately after tracheal intubation
|
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.
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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 (Estimated)
Study Completion (Estimated)
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
- VIDIPEDIIDS-25
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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