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

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

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.

Study Overview

• Status: Completed
• Conditions: Immobilization
• Intervention / Treatment: Device: Scoop stretcher; Device: Vacuum mattress

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1201
    • Genève TEAM Ambulances

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• registered paramedics or emergency medical technician (EMT) actually working in the ambulance service.

Exclusion Criteria:

• member of study investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Geneve TEAM Ambulances

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: May 16, 2021
• First Submitted That Met QC Criteria: May 23, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 23, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Emergency Medical Services; Spinal cord injury; Prehospital emergency care; Prehospital; Spinal stabilization; Scoop stretcher; Vacuum mattress
• Other Study ID Numbers: SSSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Shared upon request
• IPD Sharing Time Frame: Since publication, for 10 years
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No