Applied Forces During Neonatal Intubation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Applied Forces During Neonatal Intubation: a Randomized Crossover Mannequin Study

Conditions
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Intubation, Training, Neonate, Manikin

Intervention / Treatment
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* Procedure: Intubation with traditional laryngoscope
* Procedure: Intubation with a straight blade video laryngoscope
* Procedure: Intubation with a hyper-angulated video laryngoscope


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intubation with traditional laryngoscope<br>Participants will be required to intubate the manikin by using a traditional laryngoscope | Procedure: Intubation with traditional laryngoscope<br>* Participants will be invited to intubate the mannequin with a traditional laryngoscope<br>|
| Experimental: Intubation with a straight blade video laryngoscope<br>Participants will be required to intubate the manikin by using a straight blade video laryngoscope | Procedure: Intubation with a straight blade video laryngoscope<br>* Intubation with a straight blade video laryngoscope<br>|
| Experimental: Intubation with hyper-angulated video laryngoscope<br>Participants will be required to intubate the manikin by using a hyper-angulated video laryngoscope | Procedure: Intubation with a hyper-angulated video laryngoscope<br>* Participants will be asked to intubate the mannequin with a hyper-angulated video laryngoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forces applied to the epiglottis | 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. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forces applied to the palate | 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. | 5 minutes | 
| Perceived workload during intubation | Participants will be asked to report their perceived workload during intubation by using a validated tool | 20 minutes | 
| Time of intubation | Time elapsed frmo insertion of the laryngoscope in the mouth to his removal | 5 minutes |