Comparing two videolaryngoscopes for placing breathing tubes in infants
Comparison of the Effectiveness and Cost-Effectiveness of McGRATH™ MAC and Besdata Videolaryngoscopes in the Orotracheal Intubation of Children: A Non-Inferiority Randomized Clinical Trial
This trial will test whether the BESDATA BD-DF videolaryngoscope works as well as the McGRATH MAC for placing breathing tubes on the first try in infants aged 6 months to 3 years during elective surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | 6 Months to 3 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07351227 on ClinicalTrials.gov |
What this trial studies
This is a randomized, single-center trial at the Hospital das Clínicas (University of São Paulo) that assigns infants to intubation with either the BESDATA BD-DF or the McGRATH MAC videolaryngoscope. The primary outcome is successful orotracheal intubation on the first attempt, with secondary measures including procedure time, number of attempts, airway-related complications, and device-related costs. Infants eligible are between 6 months and 3 years undergoing elective general anesthesia, with exclusions for significant airway anomalies, hemodynamic instability, or ASA IV and above. The study combines clinical performance data with an economic comparison to inform device selection in pediatric airway management.
Who should consider this trial
Good fit: Ideal candidates are infants aged 6 months to 3 years scheduled for elective surgery under general anesthesia at the Children's Institute (Instituto da Criança) of HC-FMUSP whose parents or legal guardians provide informed consent.
Not a fit: Infants with craniofacial abnormalities or oral deformities suggesting a difficult airway, those who are hemodynamically unstable, classified ASA IV or higher, or outside the 6 months–3 years age range are excluded and unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the trial could identify a device that increases first-attempt intubation success and reduces complications and costs for infants needing airway management during surgery.
How similar studies have performed: The McGRATH MAC has been more extensively studied and commonly used in pediatrics with supportive data on visualization and success, but head-to-head comparisons with the newer BESDATA device in infants are currently lacking.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo, São Paulo
- Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Vinícius C Quintão, MD, PhD — Hospital das Clínicas HCFMUSP
- Study coordinator: Vinícius C Quintão, MD, PhD
- Email: vinicius.quintao@hc.fm.usp.br
- Phone: 5511971273950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.