Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment

NCT07351227 | Recruiting DMC FDA Device

• 1 other identifier: PANDA
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Videolaryngoscope; Pediatric orotracheal intubation; Cost effectiveness; McGrath MAC; BESDATA

Outcome Measures

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.

  From randomization until up to 15 minutes

Secondary Outcomes (1)

• Incremental cost-effectiveness ratio of videolaryngoscopes

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

Other Outcomes (4)

• Number of intubation attempts

  During anesthetic induction

• Cormack-Lehane grade

  During anesthetic induction

• Percentage of glottic opening (POGO) score

  During anesthetic induction

Study Arms (2)

McGrath MAC

ACTIVE COMPARATOR

Intubation the included participants with the McGrath MAC videolaryngoscope

Device: Intubation

BESDATA BD-DF

EXPERIMENTAL

Intubation the included participants with the BESDATA BD-DF videolaryngoscope

Device: Intubation

Interventions

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.

BESDATA BD-DF; McGrath MAC

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (5)

• Gupta A, Sharma R, Gupta N. Evolution of videolaryngoscopy in pediatric population. J Anaesthesiol Clin Pharmacol. 2021 Jan-Mar;37(1):14-27. doi: 10.4103/joacp.JOACP_7_19. Epub 2021 Apr 10.

  PMID: 34103817 BACKGROUND

• Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.

  PMID: 26705976 BACKGROUND

• Hu X, Jin Y, Li J, Xin J, Yang Z. Efficacy and safety of videolaryngoscopy versus direct laryngoscopy in paediatric intubation: A meta-analysis of 27 randomized controlled trials. J Clin Anesth. 2020 Nov;66:109968. doi: 10.1016/j.jclinane.2020.109968. Epub 2020 Jul 6.

  PMID: 32645564 BACKGROUND

• Abbas A, Samad L. Children at the heart of global surgery: children's surgery in low- and middle-income countries. J Public Health Emerg 2020;4:34.10.21037/jphe-2020-gs-08

  BACKGROUND

• Rabbitts JA, Groenewald CB. Epidemiology of Pediatric Surgery in the United States. Paediatr Anaesth. 2020 Oct;30(10):1083-1090. doi: 10.1111/pan.13993. Epub 2020 Aug 29.

  PMID: 32777147 BACKGROUND

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Vinícius C Quintão, MD, PhD

  Hospital das Clínicas HCFMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinícius C Quintão, MD, PhD

CONTACT

5511971273950; vinicius.quintao@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a prospective, randomized, double-blind clinical trial designed to evaluate the cost-effectiveness and clinical outcomes of the BESDATA BD-DF and McGrath™ MAC videolaryngoscopes in pediatric patients under one year of age undergoing elective surgery under general anesthesia requiring orotracheal intubation. 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 po

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)