NCT07351227 Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment
| NCT ID | NCT07351227 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Intubation, Intratracheal |
| Study Type | INTERVENTIONAL |
| Enrollment | 226 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 226 participants in total. It began in 2026-03-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * The study will include children aged between 6 months and 3 years who are scheduled for elective surgery under general anesthesia at the Children's Institute (Instituto da Criança - ICr) of the Hospital das Clínicas Complex, University of São Paulo Medical School (HC-FMUSP), provided that informed consent is obtained from their parents or legal guardians. Exclusion Criteria: * Patients under one year of age will be excluded if informed consent is not obtained from their legal guardians, if they are classified as ASA physical status IV or higher, present with hemodynamic instability, or have craniofacial abnormalities or oral deformities suggestive of a potentially difficult airway.
Contact & Investigator
Vinícius C Quintão, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital das Clínicas HCFMUSP
Frequently Asked Questions
Who can join the NCT07351227 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 3 Years, studying Intubation, Intratracheal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07351227 currently recruiting?
Yes, NCT07351227 is actively recruiting participants. Contact the research team at vinicius.quintao@hc.fm.usp.br for enrollment information.
Where is the NCT07351227 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07351227 clinical trial?
NCT07351227 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Vinícius C Quintão, MD, PhD at Hospital das Clínicas HCFMUSP. The trial plans to enroll 226 participants.