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

NCT04904770 | Completed

• 1 other identifier: SSSS
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Immobilization

Keywords

Spinal stabilization; Prehospital; Emergency Medical Services; Scoop stretcher; Vacuum mattress; Spinal cord injury; Prehospital 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 stretcher DEVICE

Already included in arm/group description

Scoop stretcher

Vacuum mattress DEVICE

Already included in arm/group description

Vacuum mattress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• Geneve TEAM Ambulances: lead

Study Sites (1)

Genève TEAM Ambulances

Geneva, 1201, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Loric Stuby

  Geneve TEAM Ambulances

  PRINCIPAL INVESTIGATOR

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

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: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Since publication, for 10 years
• Access Criteria: Upon request

Locations

CH (1)