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Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment

NCT07351227 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

  • Intubation, Intratracheal
  • Airway Management
  • Video Laryngoscope
  • Cost Effectiveness

Interventions

DEVICE

Intubation

Intubation of pediatric patients under one year of age undergoing elective surgery under general anesthesia requiring orotracheal intubation, with one or another videolaryngoscope device.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Vinícius C Quintão, MD, PhD · Hospital das Clínicas HCFMUSP

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07351227 on ClinicalTrials.gov