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

University Hospital Padova

Status: Not yet enrolling

Conditions: Neonatal Disease; Intubation

Treatments: Device: Videolaryngoscope and table at xiphoid level; Device: Direct laryngoscope and table at xiphoid level; Device: Direct laryngoscope and table at umbilical level; Device: Videolaryngoscope and table at umbilical level

Study type: Interventional

Funder types: Other

Identifiers

NCT06474572

NEOUNIPD5(2024)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Level III NICU and PICU consultants, and pediatric residents

Exclusion criteria

• Refusal to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Direct laryngoscope and table at xiphoid level

Active Comparator group

Description:

Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level

Treatment:

Device: Direct laryngoscope and table at xiphoid level

Videolaryngoscope and table at xiphoid level

Active Comparator group

Description:

Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level

Treatment:

Device: Videolaryngoscope and table at xiphoid level

Direct laryngoscope and table at umbilical level

Active Comparator group

Description:

Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level

Treatment:

Device: Direct laryngoscope and table at umbilical level

Videolaryngoscope and table at umbilical level

Experimental group

Description:

Participants will be required to intubate the manikin with a video laryngoscope and table at umbilical level

Treatment:

Device: Videolaryngoscope and table at umbilical level