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

Immobilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04904770
• Other study ID #: SSSS
• Status: Completed
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2021
• Source: Geneve TEAM Ambulances
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• member of study investigators

Related Conditions & MeSH terms

• Immobilization

Intervention

Device:
• Scoop stretcher
Already included in arm/group description
• Vacuum mattress
Already included in arm/group description

Locations

Country	Name	City	State
Switzerland	Genève TEAM Ambulances	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Geneve TEAM Ambulances

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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