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

Not Applicable

Not yet recruiting

• Conditions: Neonatal Disease; Intubation
• Interventions: Device: Direct laryngoscope and table at xiphoid level; Device: Videolaryngoscope and table at xiphoid level; Device: Direct laryngoscope and table at umbilical level; Device: Videolaryngoscope and table at umbilical level

• Registration Number: NCT06474572
• Lead Sponsor: University Hospital Padova

Brief 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.

Study Timeline

• Study First Submitted: 2024-05-28
• Status Verified: 2024-06
• Study Start: 2024-06
• Primary Completion: 2024-06
• Study Completion: 2024-06
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Level III NICU and PICU consultants, and pediatric residents

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Exclusion Criteria

• Refusal to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Direct laryngoscope and table at xiphoid level	Direct laryngoscope and table at xiphoid level	Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
Videolaryngoscope and table at xiphoid level	Videolaryngoscope and table at xiphoid level	Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
Direct laryngoscope and table at umbilical level	Direct laryngoscope and table at umbilical level	Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
Videolaryngoscope and table at umbilical level	Videolaryngoscope and table at umbilical level	Participants will be required to intubate the manikin with a video laryngoscope and table at umbilical level

Primary Outcome Measures

Name	Time	Method
Magnitide of applied forces (Newton)	3 minutes	Magnitude of forces (measured in Newton) applied to the epiglottis and the palate of the neonatal manikin during the intubation

Secondary Outcome Measures

Name	Time	Method
Percentage of participants achieving the intubation success at the first attempt	30 seconds	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
Total time of intubation	3 minutes	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
Participant's opinions about the procedure	12 hours	Participants will report: their preference about table height and device; perceived difficulty using a Likert scale (1= not difficult, 5=very difficult)