NCT04904770

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

June 9, 2026

Completed
Last Updated

June 9, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

May 16, 2021

Results QC Date

February 15, 2026

Last Update Submit

June 7, 2026

Conditions

Immobilization

Keywords

Spinal stabilizationPrehospitalEmergency Medical ServicesScoop stretcherVacuum mattressSpinal cord injuryPrehospital emergency care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Quality of Stabilization

    At study session (real-time assessment), in July or August

  • Level of Anxiety

    5 minutes after spinal stabilization, on a questionnaire

  • Level of Comfort

    5 minutes after spinal stabilization, on a questionnaire

  • Degree of Induced Dyspnoea or Shortness of Breath

    5 minutes after spinal stabilization, on a questionnaire

Study Arms (2)

Scoop stretcher

EXPERIMENTAL

A scoop stretcher will be used as device to perform spinal stabilization

Device: Scoop stretcher

Vacuum mattress

ACTIVE COMPARATOR

A vacuum mattress will be used as device to perform spinal stabilization

Device: Vacuum mattress

Interventions

Scoop stretcherDEVICE

Already included in arm/group description

Scoop stretcher
Vacuum mattressDEVICE

Already included in arm/group description

Vacuum mattress

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • member of study investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genève TEAM Ambulances

Geneva, Canton of Geneva, 1201, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Limitations and Caveats

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.

Results Point of Contact

Title
Stuby Loric
Organization
Genève TEAM Ambulances
l.stuby@gt-ambulances.ch
+41228001212

Study Officials

  • Loric Stuby

    Geneve TEAM Ambulances

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to nature of therapy, it is impossible to mask participants, care provider, investigators or outcomes assessors. Statistician will however be blinded to allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2021

First Posted

May 27, 2021

Study Start

June 10, 2021

Primary Completion

August 31, 2021

Study Completion

September 30, 2021

Last Updated

June 9, 2026

Results First Posted

June 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Shared upon request

Shared Documents
ICF
Time Frame
Since publication, for 10 years
Access Criteria
Upon request

Locations

CH(1)