Actively Recruiting
Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment
Led by University of Sao Paulo General Hospital · Updated on 2026-03-20
226
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to find out whether the BESDATA BD-DF videolaryngoscope works as well as the McGRATH™ MAC videolaryngoscope for placing a breathing tube in infants during surgery. The study will also compare the costs associated with using each device. The main questions this study aims to answer are: Is the BESDATA BD-DF videolaryngoscope as effective as the McGRATH™ MAC videolaryngoscope for successful placement of a breathing tube on the first attempt in infants? Are there differences between the two devices in terms of procedure time, number of attempts, airway-related complications, and overall costs? Researchers will compare infants who are intubated using the BESDATA BD-DF videolaryngoscope with infants who are intubated using the McGRATH™ MAC videolaryngoscope to see whether the two devices perform similarly and whether one is more cost-effective than the other. Participants will: Be randomly assigned to have a breathing tube placed using one of the two videolaryngoscopes; Receive standard general anesthesia for an elective surgical procedure; Have information collected during and after the procedure to assess safety, effectiveness, and costs.
CONDITIONS
Official Title
Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 6 months and 3 years
- Scheduled for elective surgery under general anesthesia
- Informed consent obtained from parents or legal guardians
- Surgery to be performed at the Children's Institute of Hospital das Cl�EDnicas Complex, University of S�e3o Paulo Medical School
You will not qualify if you...
- Lack of informed consent from parents or legal guardians for patients under one year old
- ASA physical status IV or higher
- Presence of hemodynamic instability
- Craniofacial abnormalities or oral deformities suggesting potentially difficult airway
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
Research Team
V
Vinícius C Quintão, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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