NCT05197868

Applied Forces During Neonatal Intubation

Applied Forces During Neonatal Intubation: a Randomized Crossover Mannequin Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital Padova · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study will be to compare the forces applied to mannequin airways (at epiglottis and at palate) during direct laryngoscopy and indirect video laryngoscopy with two kinds of blades (straight blade and hyper-angulated blade)

Detailed description

This is a randomized controlled crossover trial of intubation with three laryngoscope devices in a neonatal manikin model. Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study. Participants in the ABC arm will be assigned to perform the intubation with a traditional laryngoscope (A), followed by the intubation with a straight blade video laryngoscope (B) and by the intubation with hyper-angulated video laryngoscope (C). Participants in different arms will be assigned to perform the intubations in different sequences (BCA/CAB/ACB/BAC/CBA). The primary outcome measure will be the forces applied to mannequin oro-tracheal tissues during intubation with the three kinds of tools. The secondary outcome measures will be the perceived workload during intubation and intubation time with the traditional laryngoscope and the video laryngoscope.

Conditions

• Intubation
• Training
• Neonate
• Manikin

Interventions

Type	Name	Description
PROCEDURE	Intubation with traditional laryngoscope	Participants will be invited to intubate the mannequin with a traditional laryngoscope
PROCEDURE	Intubation with a straight blade video laryngoscope	Intubation with a straight blade video laryngoscope
PROCEDURE	Intubation with a hyper-angulated video laryngoscope	Participants will be asked to intubate the mannequin with a hyper-angulated video laryngoscope

Timeline

• Start date: 2022-01-20
• Primary completion: 2022-01-26
• Completion: 2022-01-26
• First posted: 2022-01-20
• Last updated: 2022-02-15

Locations

1 site across 1 country: Italy