Efficacy 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/32645564/Actively Recruiting
Led by University of Sao Paulo General Hospital · Updated on 2026-03-20
226
Participants Needed
1
Research Sites
17 weeks
Total Duration
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
Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment
V
Vinícius C Quintão, MD, PhD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
University of Sao Paulo General Hospital
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo orotracheal intubation using one of two videolaryngoscope devices during elective surgery under general anesthesia.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Xiaoxue Hu, Yi Jin, Jiansong Li...
https://pubmed.ncbi.nlm.nih.gov/32645564/John Edem Fiadjoe, Akira Nishisaki, Narasimhan Jagannathan...
https://pubmed.ncbi.nlm.nih.gov/26705976/Anju Gupta, Ridhima Sharma, Nishkarsh Gupta
https://pubmed.ncbi.nlm.nih.gov/34103817/Jennifer A Rabbitts, Cornelius B Groenewald
https://pubmed.ncbi.nlm.nih.gov/32777147/University of Sao Paulo General Hospital
Lead Sponsor