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| Name | Class |
|---|---|
| Geneve TEAM Ambulances | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scoop stretcher | Experimental | A scoop stretcher will be used as device to perform spinal stabilization |
|
| Vacuum mattress | Active Comparator | A vacuum mattress will be used as device to perform spinal stabilization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scoop stretcher | Device | Already included in arm/group description |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Stabilization | Quality of stabilization (accuracy of tightening of restraints belts) regarding the standard operating procedure, in a dichotomous manner (sufficient vs insufficent). | At study session (real-time assessment), in July or August |
| Level of Anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loric Stuby | Geneve TEAM Ambulances | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genève TEAM Ambulances | Geneva | Canton of Geneva | 1201 | Switzerland |
Shared upon request
Since publication, for 10 years
Upon request
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| ID | Title | Description |
|---|---|---|
| FG000 | Scoop Stretcher | A scoop stretcher was used as device to perform spinal stabilization |
| FG001 | Vacuum Mattress | A vacuum mattress was used as device to perform spinal stabilization |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Scoop Stretcher | A scoop stretcher was used as device to perform spinal stabilization |
| BG001 | Vacuum Mattress | A vacuum mattress was used as device to perform spinal stabilization |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | seconds | At study session (real-time assessment), in July or August |
|
From enrollment until end of the study (up to 1 hour)
No adverse events as it was no risk to participants (simulation study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Scoop Stretcher | A scoop stretcher was used as device to perform spinal stabilization |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stuby Loric | Genève TEAM Ambulances | +41228001212 | l.stuby@gt-ambulances.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2026 | Feb 15, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Randomized Controlled Trial
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Due to nature of therapy, it is impossible to mask participants, care provider, investigators or outcomes assessors. Statistician will however be blinded to allocation.
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| Vacuum mattress |
| Device |
Already included in arm/group description |
|
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 |
| 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Quality of Stabilization | Quality of stabilization (accuracy of tightening of restraints belts) regarding the standard operating procedure, in a dichotomous manner (sufficient vs insufficent). | Number of stabilization procedures correctly performed regarding the standard operating procedure. | Posted | Number | Stabilization procedures | At study session (real-time assessment), in July or August | Stabilization procedures | Stabilization procedures |
|
|
|
| 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". | Posted | Median | Inter-Quartile Range | Point (on a scale from 0 to 10) | 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". | Posted | Median | Inter-Quartile Range | Point (on a scale from 0 to 10) | 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". | Posted | Median | Inter-Quartile Range | Point (on a scale from 0 to 10) | 5 minutes after spinal stabilization, on a questionnaire |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Vacuum Mattress | A vacuum mattress was used as device to perform spinal stabilization | 0 | 7 | 0 | 7 | 0 | 7 |
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| D014947 | Wounds and Injuries |