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Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial

Intubation; Difficult or Failed Clinical Trial

Official title:
Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial

Clinical Trial Summary

The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure. This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn.

Clinical Trial Description

Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Furthermore, the procedure times are often longer than recommended by international guidelines, and repeated intubation attempts are associated with adverse events in unstable neonates. Objectives: To compare success and time of intubation through intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure. Methods: This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure was the intubation success rate at the first attempt. Secondary outcome measures were the total time needed for the endotracheal tube positioning (calculated as the sum of the time of device positioning in all attempts), and the participant's opinion on using the device (evaluated using a Likert scale). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06263790
Study type Interventional
Source University Hospital Padova
Contact Daniele Trevisanuto
Phone 3406632734
Email daniele.trevisanuto@unipd.it
Status Not yet recruiting
Phase N/A
Start date March 2024
Completion date March 2024
View Details
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