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Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment

ConditionsIntubation, IntratrachealAirway ManagementVideo LaryngoscopeCost Effectiveness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-3
SponsorUniversity of Sao Paulo General Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intubation

    Device

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

Treatment groups

226 Participants
are divided into 2 treatment groups
Group A: McGrath MACActive comparator 1 intervention
Group B: BESDATA BD-DFExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

First-attempt intubation success

Proportion of participants in whom successful orotracheal intubation is achieved on the first laryngoscopy attempt using the allocated videolaryngoscope, without the need for additional attempts or device change.

Time frame
From randomization until up to 15 minutes

Secondary outcomes

1

Incremental cost-effectiveness ratio of videolaryngoscopes

Cost-effectiveness will be assessed using the Incremental Cost-Effectiveness Ratio (ICER), calculated as the difference in total cost per patient (unit: US dollars) between the BESDATA BD-DF and McGRATH™ MAC devices divided by the difference in effectiveness, defined as the rate of successful first-attempt intubation (unit: percentage). Total costs will include device and consumable expenses and direct hospital costs related to postoperative complications and additional length of stay.

Time frame
From the day of surgery until hospital discharge (up to 30 days postoperatively)

Other outcomes

1

Number of intubation attempts

Number of intubation attempts

Time frame
During anesthetic induction
2

Cormack-Lehane grade

Cormack-Lehane grade

Time frame
During anesthetic induction
3

Percentage of glottic opening (POGO) score

Percentage of glottic opening (POGO) score

Time frame
During anesthetic induction
4

Intubation-related complications.

Intubation-related complications, including mechanical trauma and desaturation;

Time frame
During anesthetic induction

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo General Hospital

Lead sponsor

Source ClinicalTrials.gov
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