Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment (PANDA)

March 18, 2026 updated by: Vinícius C Quintão, MD, MSc, PhD, University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Airway management in infants and young children is technically challenging and carries a higher risk of complications than in older pediatric or adult patients. Achieving successful orotracheal intubation on the first attempt is particularly important in this population due to limited oxygen reserves and increased vulnerability to hypoxia, airway trauma, and hemodynamic instability. Videolaryngoscopy has been introduced as an alternative to conventional direct laryngoscopy with the potential to improve glottic visualization and intubation success. However, evidence comparing different videolaryngoscopy devices in infants remains limited, and there is currently no consensus regarding the optimal device for this age group.

Although several videolaryngoscopes are available on the market, most comparative studies have focused on adult populations. In pediatrics, and especially in infants under one year of age, published data are scarce. The McGRATH™ MAC videolaryngoscope has been more extensively studied and is widely used in clinical practice. In contrast, the BESDATA BD-DF videolaryngoscope is a newer device with very limited clinical evidence, and no head-to-head trials have compared it with other videolaryngoscopes in children. Furthermore, despite the increasing adoption of videolaryngoscopy, the economic impact of using different devices has not been adequately investigated in pediatric settings.

This study is designed to address these gaps by comparing the clinical performance and cost-effectiveness of the BESDATA BD-DF and McGRATH™ MAC videolaryngoscopes in infants undergoing elective surgery under general anesthesia. The trial will evaluate whether the BESDATA device is non-inferior to the McGRATH device in terms of intubation effectiveness while also assessing relevant economic outcomes associated with each technology.

The study will be conducted as a prospective, randomized, double-blind clinical trial at a tertiary pediatric center. Participants will be randomly allocated to undergo tracheal intubation with one of the two videolaryngoscopes. All procedures will be performed by trained anesthesiologists experienced with both devices, and data will be collected using a standardized protocol in a secure electronic database.

In addition to comparing clinical performance, the study will include an economic evaluation that considers the costs of device acquisition, required consumables, and expenses related to potential postoperative complications associated with airway management. This integrated approach aims to provide clinically meaningful and economically relevant information to support evidence-based decision-making in pediatric anesthesia.

By directly comparing two videolaryngoscopy systems in a randomized design, this trial seeks to generate high-quality evidence regarding the most effective and sustainable option for airway management in infants. The results are expected to inform clinical practice, guide resource allocation, and contribute to safer perioperative care for pediatric patients.

Study Type

Interventional

Enrollment (Estimated)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403-000
        • Recruiting
        • Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo
        • Contact:
        • Sub-Investigator:
          • Lucas F Pereira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: McGrath MAC
Intubation the included participants with the McGrath MAC videolaryngoscope
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.
Experimental: BESDATA BD-DF
Intubation the included participants with the BESDATA BD-DF videolaryngoscope
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First-attempt intubation success
Time Frame: From randomization until up to 15 minutes
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.
From randomization until up to 15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental cost-effectiveness ratio of videolaryngoscopes
Time Frame: From the day of surgery until hospital discharge (up to 30 days postoperatively)
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.
From the day of surgery until hospital discharge (up to 30 days postoperatively)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of intubation attempts
Time Frame: During anesthetic induction
Number of intubation attempts
During anesthetic induction
Cormack-Lehane grade
Time Frame: During anesthetic induction
Cormack-Lehane grade
During anesthetic induction
Percentage of glottic opening (POGO) score
Time Frame: During anesthetic induction
Percentage of glottic opening (POGO) score
During anesthetic induction
Intubation-related complications.
Time Frame: During anesthetic induction
Intubation-related complications, including mechanical trauma and desaturation;
During anesthetic induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Vinícius C Quintão, MD, PhD, Hospital das Clínicas HCFMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No, individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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