NCT06474572

Applied Forces During Neonatal Intubation at Different Heights of the Resuscitation Table

Applied Forces During Neonatal Intubation With Direct and Video Laryngoscopy at Different Heights of the Resuscitation Table: a Randomized Crossover Manikin Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: University Hospital Padova · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study aims to compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time and participants' opinion on the procedures were investigated. This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table.

Detailed description

Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Some procedure-related aspects may affect the quality of the intubation. Optimizing the relative height between patient and operator may improve intubation procedures. Objectives: To compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time, and participants' opinions on the procedures were investigated. Methods: This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Participants will be Level III NICU/PICU consultants, and pediatric residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the forces applied on the neonatal manikin during the intubation. The secondary outcome measures will be the success of the first attempt, the total time of intubation, and participants' opinions about the procedure.

Conditions

• Neonatal Disease
• Intubation

Interventions

Type	Name	Description
DEVICE	Direct laryngoscope and table at xiphoid level	Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
DEVICE	Videolaryngoscope and table at xiphoid level	Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
DEVICE	Direct laryngoscope and table at umbilical level	Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
DEVICE	Videolaryngoscope and table at umbilical level	Participants will be required to intubate the manikin with a videolaryngoscope and table at umbilical level

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2024-06-25
• Last updated: 2024-06-25