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Completed

NCT Number: NCT05197868

Applied Forces During Neonatal Intubation

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)

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Key information

Conditions

Intubation Manikin Neonate Training

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Padova

Padova, 35128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intubation with traditional laryngoscope

Procedure

Participants will be invited to intubate the mannequin with a traditional laryngoscope

Intubation with a straight blade video laryngoscope

Procedure

Intubation with a straight blade video laryngoscope

Intubation with a hyper-angulated video laryngoscope

Procedure

Participants will be asked to intubate the mannequin with a hyper-angulated video laryngoscope

Primary outcomes

  1. Forces applied to the epiglottis

    Time frame: 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 outcomes

  1. Forces applied to the palate

    Time frame: 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.

  2. Perceived workload during intubation

    Time frame: 20 minutes

    Participants will be asked to report their perceived workload during intubation by using a validated tool

  3. Time of intubation

    Time frame: 5 minutes

    Time elapsed frmo insertion of the laryngoscope in the mouth to his removal

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Official study title

Applied Forces During Neonatal Intubation: a Randomized Crossover Mannequin Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2022
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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