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

Completed

Conditions: Medical and Surgical,

Registration Number: CTRI/2021/12/038787

Lead Sponsor: JIPMER

Brief Summary: The anatomy of airway in infants is significantly different than of adults. Multiple anatomic differences like large tongue, floppy epiglottis, more anterior situated larynx, large occiput, smaller diameter of the airway make direct laryngoscopy and intubation difficult. Also the anesthetised neonates and infants are prone for hypoxia even with minor delay in airway management.The conventional direct laryngoscopy though commonly used and successful is limited by the requirement of alignment of line of sight of anesthetist with axis of laryngoscopic inlet. Video laryngoscope whereas uses video camera for focused view over the laryngeal inlet thereby obviating the need of alignment of laryngeal axis. Due to better glottic visualization video laryngoscopy can reduce number of intubation attempts and first attempt intubation success rate.

Therefore in this study we compare direct laryngoscope using age appropriate size miller blade with besdata video laryngoscope using zero size miller blade in term neonates and infants upto 6 months of age. With this comparison if video laryngoscope is equivalent to direct laryngoscope,then based on the results of the study video laryngoscope can be used as an alternative to direct laryngoscope in emergency and elective pediatric intubation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 age	Baseline

Secondary Outcome Measures

Name	Time	Method
Time for best glottic visualization	Baseline
To compare first attempt intubation success rate	NA
To compare POGO Score (Percentage of Glottic opening) between the two groups	NA
To assess for development of complications such as airway mucosal trauma, bradycardia, esophageal intubation.	NA

Trial Locations

Locations (1): JIPMER
🇮🇳
Pondicherry, PONDICHERRY, India
JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
Dr Vedha Venkatesh
Principal investigator
8940183742
sundarvedhavenkatesh@gmail.com