Time Performance of Scoop Stretcher Versus Vacuum Mattress for Prehospital Spinal Stabilization

Study Overview
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Brief Summary
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A simulation-based randomized controlled trial was designed with the objective to assess the time needed to achieve spinal stabilization using a scoop stretcher compared to a vacuum mattress.

Detailed Description
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A simulation-based randomized controlled trial was designed with the objective to assess the time needed to achieve spinal stabilization using a scoop stretcher compared to a vacuum mattress. The participants will be recruited among healthcare workers from one Emergency Medical Service. Then, the participants will first act as patient and undergo spinal stabilization from an other team, afterwards they will have to complete a spinal stabilization either using a scoop stretcher or a vacuum mattress, depending on allocation regarding randomization. The sessions will be video recorded to allow subsequent assessment.

Official Title
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Time Performance of Scoop Stretcher Versus Vacuum Mattress for Prehospital Spinal Stabilization: Open-Label Simulation-based Randomized Controlled Trial

Conditions
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Immobilization

Intervention / Treatment
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* Device: Scoop stretcher
* Device: Vacuum mattress


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: registered paramedics or emergency medical technician (EMT) actually working in the ambulance service. Exclusion Criteria: member of study investigators

Ages Eligible for Study
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Minimum Age: 18 Years

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: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scoop stretcher<br>A scoop stretcher will be used as device to perform spinal stabilization | Device: Scoop stretcher<br>* Already included in arm/group description<br>|
| Active Comparator: Vacuum mattress<br>A vacuum mattress will be used as device to perform spinal stabilization | Device: Vacuum mattress<br>* Already included in arm/group description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in time to perform the procedure | The time required to complete the procedure from the team leader's order to start, until the device is left up from the ground, measured in seconds. | At study session (real-time assessment), in July or August | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of stabilization | Quality of stabilization (accuracy of tightening of restraints belts) regarding the standard operating procedure | At study session (real-time assessment), in July or August | 
| Level of anxiety | Participants will estimate their level of anxiety on a visual analog scale from 0 = No anxiety at all to 10 = The worst anxiety imaginable. | 5 minutes after spinal stabilization, on a questionnaire | 
| Level of comfort | Participants will estimate their level of comfort on a visual analog scale from 0 = Very, very comfortable to 10 = Very, very uncomfortable. | 5 minutes after spinal stabilization, on a questionnaire | 
| Degree of induced dyspnoea or shortness of breath | Participants will estimate their degree of induced dyspnoea or shortness of breath on a visual analog scale from 0 = No dyspnoea or shortness of breath to 10 = The worst imaginable dyspnoea. | 5 minutes after spinal stabilization, on a questionnaire | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency Medical Services, Vacuum mattress, Spinal cord injury, Prehospital emergency care, Spinal stabilization, Prehospital, Scoop stretcher