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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Switzerland1 site

Genève TEAM Ambulances
Geneva, Canton of Geneva, 1201

Other trials in Switzerland

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 groups in NCT04904770
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.

10 Jun 202130 Sep 2021

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
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Single-center Transformational Study on Feasibility and Efficacy of Respiratory Motion Management Using Novel Position Fixation Device for Lung Cancer Patients Undergoing Stereotactic Body Radiation Therapy(2023 No.358 Project)
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Not yet recruiting
Radiotherapy In a Sitting Position for Enhanced Reproducibility
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RecruitingObservational study
TRiP-cast Score Validation and Evaluation of Adherence to Preventive Anticoagulant Treatment in Patients With Lower Limb Trauma Requiring Immobilization
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All Immobilization trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Time Performance of Scoop Stretcher Versus Vacuum Mattress for Prehospital Spinal Stabilization: Open-Label Simulation-based Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04904770
Acronym / sponsor ID: SSSS
Conditions: Immobilization
Keywords: Spinal stabilization, Prehospital, Emergency Medical Services, Scoop stretcher, Vacuum mattress, Spinal cord injury, Prehospital emergency care
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Stuby LoricUniversity, hospital or other
Collaborators: Geneve TEAM Ambulances
Study start: 10 Jun 2021 (actual)
Primary completion: 31 Aug 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 27 May 2021 (actual)
Results: Posted 9 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized Controlled Trial

Arm	Type	Receives
Scoop stretcher	Experimental	Device: Scoop stretcherA scoop stretcher will be used as device to perform spinal stabilization
Vacuum mattress	Active comparator	Device: Vacuum mattressA vacuum mattress will be used as device to perform spinal stabilization

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

member of study investigators

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Scoop stretcherAlready included in arm/group description	Device	Scoop stretcher
Vacuum mattressAlready included in arm/group description	Device	Vacuum mattress

Primary outcome

Change in Time to Perform the Procedure
Time frame: At study session (real-time assessment), in July or August
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.

4 secondary outcomes

Quality of Stabilization
Time frame: At study session (real-time assessment), in July or August
Level of Anxiety
Time frame: 5 minutes after spinal stabilization, on a questionnaire
Level of Comfort
Time frame: 5 minutes after spinal stabilization, on a questionnaire
Degree of Induced Dyspnoea or Shortness of Breath
Time frame: 5 minutes after spinal stabilization, on a questionnaire

Results and safety

Results posted to the registry on 9 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Scoop Stretcher	8	8
Vacuum Mattress	7	7

Primary outcome: Change in Time to Perform the Procedure

Time frame: At study session (real-time assessment), in July or August. Median (Inter-Quartile Range). Unit: seconds

Measure	Scoop Stretcher n = 8	Vacuum Mattress n = 7
Value	127 (111 to 145)	212 (156 to 237)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of the study (up to 1 hour). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Scoop Stretcher	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Vacuum Mattress	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Limitations and caveats (from the sponsor): It is important to acknowledge that the reported times are applicable only when all the required equipment is readily available at the scene. Several factors should be taken into account when interpreting the results. The study's design was monocentric, and the participants involved healthy volunteers rather than actual patients. Additionally, the sample size was small, which may limit the generalizability of the findings. Open-label design, subject to possible bias.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Shared upon request

Related trials for Immobilization

RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Enrolling by invitation
Single-center Transformational Study on Feasibility and Efficacy of Respiratory Motion Management Using Novel Position Fixation Device for Lung Cancer Patients Undergoing Stereotactic Body Radiation Therapy(2023 No.358 Project)
Non-Small Cell Carcinoma of Lung
Not yet recruiting
Radiotherapy In a Sitting Position for Enhanced Reproducibility
Head & Neck Cancer
RecruitingObservational study
TRiP-cast Score Validation and Evaluation of Adherence to Preventive Anticoagulant Treatment in Patients With Lower Limb Trauma Requiring Immobilization
Lower Extremity Injuries, Venous Thromboembolism (VTE)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Loric Stuby principal investigator

Geneve TEAM Ambulances

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Scoop stretcher and Vacuum mattress in people with Immobilization, run by Stuby Loric at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Time to Perform the Procedure (time frame: At study session (real-time assessment), in July or August). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04904770.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.