Comparing two videolaryngoscopes for placing breathing tubes in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.