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

University Hospital Padova

Status: Not yet enrolling

Conditions: Neonatal Disease; Intubation; Difficult or Failed

Treatments: Device: Intubating laryngeal mask; Device: Direct laryngoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06263790

NEOUNIPD1(2024)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Level III NICU consultants and residents will be eligible to participate in the study

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intubation via laryngeal mask

Experimental group

Description:

Participants will be required to position the endotracheal tube in the manikin via a laryngeal mask

Treatment:

Device: Intubating laryngeal mask

Intubation via direct laryngoscope

Active Comparator group

Description:

Participants will be required to position the endotracheal tube in the manikin via direct laryngoscopy

Treatment:

Device: Direct laryngoscopy