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Comparison between two laryngoscopes in term neonates and babies upto 6 months of age

Comparison of besdata video laryngoscope with direct laryngoscope in term neonates and infants upto 6 months of age- A randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038787
Enrollment
80
Registered
2021-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Intubation by video laryngoscope: Intubation with besdata video laryngoscope using miller zero size will be done and time taken for successful intubation,glottic visualization time and

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Full term Neonates and infants upto 6 months with ASA class I and II requiring general anaesthesia with orotracheal intubation for any surgical procedure

Exclusion criteria

Exclusion criteria: 1)Patients with increased risk of gastric regurgitation and aspiration (which includes patients with anomalies like congenital diaphragmatic hernia and intestinal obstruction) 2) Patients with congenital airway anomalies 3) Patients with anticipated difficult airway (which includes patients with hydrocephalus and syndromes with features like micrognathia and retrognathia) 4) Active upper respiratory tract infection

Design outcomes

Primary

MeasureTime frame
To compare the time taken for successful tracheal intubation with Besdata video laryngoscope and Miller direct laryngoscope in term neonates and infants up to 6 months of ageTimepoint: Baseline

Secondary

MeasureTime frame
Time for best glottic visualizationTimepoint: Baseline;To assess for development of complications such as airway mucosal trauma, bradycardia, esophageal intubation.Timepoint: NA;To compare first attempt intubation success rateTimepoint: NA;To compare POGO Score (Percentage of Glottic opening) between the two groupsTimepoint: NA

Countries

India

Contacts

Public ContactDr Vedha Venkatesh

JIPMER

gnansdr@gmail.com9487188275

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026