Evolution of videolaryngoscopy in pediatric population.
Anju Gupta, Ridhima Sharma, Nishkarsh Gupta
https://pubmed.ncbi.nlm.nih.gov/34103817Actively Recruiting
Phase Not Applicable
Age: 6Months - 3Years
All Genders
Healthy Volunteers
ID07351227
Comparison of the Effectiveness and Cost-Effectiveness of McGRATH™ MAC and BESDATA BD-DF Videolaryngoscopes for Orotracheal Intubation in Children Aged 6 Months to 3 Years
Led by University of Sao Paulo General Hospital · Updated on 2026-03-20
226
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare how well two videolaryngoscopes, the BESDATA BD-DF and the McGRATH™ MAC, work for placing breathing tubes in infants during surgery. The study focuses on infants aged between 6 months and 3 years undergoing elective surgery and seeks to determine if the newer BESDATA device performs as effectively as the widely used McGRATH device. It also investigates differences in procedure time, number of attempts, airway-related complications, and overall costs associated with each device. Participants will be randomly assigned to one of two groups: one group will have their breathing tube placed using the McGRATH™ MAC videolaryngoscope, while the other group will use the BESDATA BD-DF device. All infants will receive standard general anesthesia for their surgery. The study is conducted as a prospective, randomized, single-blind clinical trial at a pediatric center, with trained anesthesiologists performing all intubations using a standardized protocol. During and after the procedure, researchers will collect data to assess the safety and effectiveness of each device, including the success of first-attempt intubation within 15 minutes. They will also evaluate economic outcomes by tracking costs related to device use, consumables, and any postoperative complications up to 30 days after surgery. The study aims to provide valuable evidence to guide clinical decisions and resource use in pediatric anesthesia.
CONDITIONS
Brief Title
Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment
Who Can Participate
Age: 6Months - 3Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Children aged between 6 months and 3 years
- Scheduled for elective surgery under general anesthesia
- Informed consent obtained from parents or legal guardians
- Surgical procedures performed at the Children's Institute of the University of São Paulo Medical School
You will not qualify if you...
- Children under one year old without informed consent from legal guardians
- Classified as ASA physical status IV or higher
- Presenting hemodynamic instability
- Having craniofacial abnormalities or oral deformities suggestive of difficult airway management
- Lack of informed consent from legal guardians for children under one year old or others as applicable in the study protocol
- Any condition that might complicate airway management as judged by the study team or protocol criteria (implied by craniofacial abnormalities and hemodynamic instability criteria in source text, preserved as separate bullet points for clarity and patient understanding where possible). If specific implied criteria are not explicit in the source, they are omitted in strict adherence to source text only, so only those explicitly mentioned are included here as exclusion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of surgery
Participants undergo orotracheal intubation using one of two videolaryngoscope devices during elective surgery under general anesthesia.
1 visit (in-person)
Post-operative Follow-up
Duration - Up to 30 days postoperatively
Participants are observed for up to 30 days after surgery to assess clinical outcomes and economic impacts related to airway management.
Visits during hospital stay until discharge
Trial Site Locations
Total: 1 location
1
Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
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Research Team
V
Vinícius C Quintão, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Published Research Related To This Trial
Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis.
John Edem Fiadjoe, Akira Nishisaki, Narasimhan Jagannathan...
https://pubmed.ncbi.nlm.nih.gov/26705976Efficacy and safety of videolaryngoscopy versus direct laryngoscopy in paediatric intubation: A meta-analysis of 27 randomized controlled trials.
Xiaoxue Hu, Yi Jin, Jiansong Li...
https://pubmed.ncbi.nlm.nih.gov/32645564Epidemiology of Pediatric Surgery in the United States.
Jennifer A Rabbitts, Cornelius B Groenewald
https://pubmed.ncbi.nlm.nih.gov/32777147