Applied Forces During Neonatal Intubation

University Hospital Padova

Status: Completed

Conditions: Manikin; Neonate; Training; Intubation

Treatments: Procedure: Intubation with traditional laryngoscope; Procedure: Intubation with a straight blade video laryngoscope; Procedure: Intubation with a hyper-angulated video laryngoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT05197868

NEOUNIPD1

Details and patient eligibility

About

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)

Full 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.

Enrollment: 30 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study.

Exclusion criteria

• Refusal to participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Intubation with traditional laryngoscope

Active Comparator group

Description:

Participants will be required to intubate the manikin by using a traditional laryngoscope

Treatment:

Procedure: Intubation with traditional laryngoscope

Intubation with a straight blade video laryngoscope

Experimental group

Description:

Participants will be required to intubate the manikin by using a straight blade video laryngoscope

Treatment:

Procedure: Intubation with a straight blade video laryngoscope

Intubation with hyper-angulated video laryngoscope

Experimental group

Description:

Participants will be required to intubate the manikin by using a hyper-angulated video laryngoscope

Treatment:

Procedure: Intubation with a hyper-angulated video laryngoscope