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

Not Applicable

Not yet recruiting

• Conditions: Intubation; Difficult or Failed; Neonatal Disease
• Interventions: Device: Direct laryngoscopy; Device: Intubating laryngeal mask

• Registration Number: NCT06263790
• Lead Sponsor: University Hospital Padova

Brief 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.

Detailed 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 Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-08
• Last Update Submitted: 2024-02-08
• Study First Posted: 2024-02-16
• Last Update Posted: 2024-02-16
• Study Start: 2024-03
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intubation via direct laryngoscope	Direct laryngoscopy	Participants will be required to position the endotracheal tube in the manikin via direct laryngoscopy
Intubation via laryngeal mask	Intubating laryngeal mask	Participants will be required to position the endotracheal tube in the manikin via a laryngeal mask

Primary Outcome Measures

Name	Time	Method
Success at the first attempt	3 minutes after the initiation of the procedure	The success of the first attempt will be defined as the achievement of the correct positioning of the endotracheal tube in the trachea as assessed by the external observer.

Secondary Outcome Measures

Name	Time	Method
Participant's opinion on difficulty of the procedure	5 minutes after end of the procedure	Participants will report their opinion on insertion difficulty and overall difficulty using a Likert scale (1= not difficult, 5=very difficult)
Time of device positioning	3 minutes after the initiation of the procedure	Time of device positioning will be calculated as the sum of the time of device positioning in all attempts, as the procedure will be repeated in case of incorrect positioning