ImmobilizationNCT04904770
Time Performance of Scoop Stretcher Versus Vacuum Mattress for Prehospital Spinal Stabilization
A study testing Scoop stretcher and Vacuum mattress in people with Immobilization, run by Stuby Loric at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immobilization
- What is being tested?
- Scoop stretcher and Vacuum mattress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jun 2021to 30 Sep 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- registered paramedics or emergency medical technician (EMT) actually working in the ambulance service.
Who cannot join
- member of study investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Immobilization
- Being tested
- Scoop stretcher, Vacuum mattress
- Keywords
- Spinal stabilization, Prehospital, Emergency Medical Services, Scoop stretcher, Vacuum mattress, Spinal cord injury, Prehospital emergency care
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoop stretcherDevice
Already included in arm/group description
Vacuum mattressDevice
Already included in arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Scoop stretcher | Experimental | A scoop stretcher will be used as device to perform spinal stabilization Receives: Device: Scoop stretcher |
| Vacuum mattress | Active comparator | A vacuum mattress will be used as device to perform spinal stabilization Receives: Device: Vacuum mattress |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study session (real-time assessment), in July or August
Secondary outcomes (4)
Quality of Stabilization
Quality of stabilization (accuracy of tightening of restraints belts) regarding the standard operating procedure, in a dichotomous manner (sufficient vs insufficent).
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 5 minutes after spinal stabilization, on a questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start10 Jun 2021
- Primary completion31 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ImmobilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stuby Loric
- Sponsor type
- University, hospital or other
- Collaborators
- Geneve TEAM Ambulances
- Responsible party
- Sponsor-investigator, Stuby Loric, Geneve TEAM Ambulances
- Investigators
- Loric Stuby, Principal investigator, Geneve TEAM Ambulances
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904770
- Sponsor's protocol ID
- SSSS
- Status last verified
- Apr 2026
- First submitted
- 16 May 2021
- Last updated
- 9 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared upon request