Applied Forces During Neonatal Intubation

Not Applicable

Completed

• Conditions: Intubation; Training; Neonate; Manikin
• Interventions: Procedure: Intubation with a straight blade video laryngoscope; Procedure: Intubation with a hyper-angulated video laryngoscope; Procedure: Intubation with traditional laryngoscope

• Registration Number: NCT05197868
• Lead Sponsor: University Hospital Padova

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-28
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-05
• Study Start: 2022-01-20
• Study First Posted: 2022-01-20
• Primary Completion: 2022-01-26
• Study Completion: 2022-01-26
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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
Intubation with a straight blade video laryngoscope	Intubation with a straight blade video laryngoscope	Participants will be required to intubate the manikin by using a straight blade video laryngoscope
Intubation with hyper-angulated video laryngoscope	Intubation with a hyper-angulated video laryngoscope	Participants will be required to intubate the manikin by using a hyper-angulated video laryngoscope
Intubation with traditional laryngoscope	Intubation with traditional laryngoscope	Participants will be required to intubate the manikin by using a traditional laryngoscope

Primary Outcome Measures

Name	Time	Method
Forces applied to the epiglottis	5 minutes	The peak force (maximum force, expressed as Newton) applied on the epiglottis during intubation will be recorded by sensors positioned on the tip of the laryngoscope's blade.

Secondary Outcome Measures

Name	Time	Method
Forces applied to the palate	5 minutes	The peak force (maximum force, expressed as Newton) applied on the palate during intubation will be recorded by sensors positioned on the posterior side of the laryngoscope's blade.
Perceived workload during intubation	20 minutes	Participants will be asked to report their perceived workload during intubation by using a validated tool
Time of intubation	5 minutes	Time elapsed frmo insertion of the laryngoscope in the mouth to his removal

Trial Locations

Locations (1)

University Hospital of Padova; 🇮🇹 Padova, Italy