Mass CasualtyNCT01310504
The Use of the FAST (Focused Abdominal Scan for Trauma) Scan by Paramedics in Mass Casualty Incidents
A study testing SonoSite Ultrasound in people with Mass Casualty, run by Ascension Health at 1 site in United States.
Trial summary
Initially a group of paramedics will be trained to perform FAST (Focused Abdominal Scan for Trauma) scans. The paramedics will then enter a simulated mass causality incident and triage patients. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mass Casualty
- What is being tested?
- SonoSite Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Paramedic - at least one year in the field, physically able to perform the test
- Patients:
- (10)peritoneal dialysis patient that are able to leave dialysate in abdominal cavity for the duration of the test
- (10) subjects not on peritoneal dialysis who are available for the duration of the test
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
About this study
Official title: The Use of the FAST Scan by Paramedics in Mass Casualty Incidents
Initially a group of paramedics will be trained to perform FAST (Focused Abdominal Scan for Trauma) scans. The paramedics will then enter a simulated mass causality incident and triage patients. Volunteers in the study will include peritoneal dialysis patients ("non stable") and non-peritoneal dialysis patients ("stable"). They will use the ultrasound to perform FAST scans on the patients to determine which subjects are "stable" and which are "unstable" patients. They will record which patients they consider need transport first. This data will be used to evaluate accuracy and speed of the FAST scan. When the paramedic identifies free fluid within the volunteer, they will be able to make the decision to upgrade these patients and ultimately transport them more quickly. The paramedics will be evaluated for time and accuracy with the FAST scan.
Read the detailed description
Ultrasound and the FAST (Focused Abdominal Scan for Trauma) scan is currently being used in the Emergency Department to help evaluate trauma patients. In the field a paramedic will use the START (Simple Triage Rapid Treatment) triage procedure to evaluate many patients and to help decide which patients are more critical and therefore need to be transported first. This study aims to create a mass casualty environment through the use of 10 volunteers who are on peritoneal dialysis and 10 patients who are not.
- Conditions
- Mass Casualty
- Being tested
- SonoSite Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoSite UltrasoundProcedure or surgery
Will be moulaged to resemble a peritoneal dialysis patient. Paramedics will scan the abdomen and determine it there's fluid within.
SonoSite UltrasoundProcedure or surgery
Paramedics will scan the abdomen and determine it there's fluid within.
| Study group | Role | What they receive |
|---|---|---|
| Non peritoneal dialysis patient | Active comparator | Not described Receives: Procedure: SonoSite Ultrasound |
| Peritoneal dialysis patient | Active comparator | Not described Receives: Procedure: SonoSite Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the use of the ultra sound and FAST scans in a simulation of a mass causality incident by paramedics for accuracy and speed
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mass CasualtyStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, J. Andrew Cusser, Ascension Health
- Investigators
- James A Cusser, MD, Principal investigator, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310504
- Sponsor's protocol ID
- ME 10 0050
- Status last verified
- Aug 2012
- First submitted
- 7 Mar 2011
- Last updated
- 17 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the FAST Scan by Paramedics in Mass Casualty Incidents
- ClinicalTrials.gov ID
- NCT01310504
- Acronym / sponsor ID
- ME 10 0050
- Conditions
- Mass Casualty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ascension HealthIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Initially a group of paramedics will be trained to perform FAST (Focused Abdominal Scan for Trauma) scans. The paramedics will then enter a simulated mass causality incident and triage patients. Volunteers in the study will include peritoneal dialysis patients ("non stable") and non-peritoneal dialysis patients ("stable"). They will use the ultrasound to perform FAST scans on the patients to determine which subjects are "stable" and which are "unstable" patients. They will record which patients they consider need transport first. This data will be used to evaluate accuracy and speed of the FAST scan. When the paramedic identifies free fluid within the volunteer, they will be able to make the decision to upgrade these patients and ultimately transport them more quickly. The paramedics will be evaluated for time and accuracy with the FAST scan.
Detailed description
Ultrasound and the FAST (Focused Abdominal Scan for Trauma) scan is currently being used in the Emergency Department to help evaluate trauma patients. In the field a paramedic will use the START (Simple Triage Rapid Treatment) triage procedure to evaluate many patients and to help decide which patients are more critical and therefore need to be transported first. This study aims to create a mass casualty environment through the use of 10 volunteers who are on peritoneal dialysis and 10 patients who are not.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non peritoneal dialysis patient | Active comparator | Procedure: SonoSite Ultrasound |
| Peritoneal dialysis patient | Active comparator | Procedure: SonoSite Ultrasound |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Paramedic - at least one year in the field, physically able to perform the test
- (10)peritoneal dialysis patient that are able to leave dialysate in abdominal cavity for the duration of the test
- (10) subjects not on peritoneal dialysis who are available for the duration of the test
Key exclusion criteria (1 listed)
- Under 18 years of age
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 |
|---|---|---|
| SonoSite UltrasoundWill be moulaged to resemble a peritoneal dialysis patient. Paramedics will scan the abdomen and determine it there's fluid within. | Procedure or surgery | Non peritoneal dialysis patient |
| SonoSite UltrasoundParamedics will scan the abdomen and determine it there's fluid within. | Procedure or surgery | Peritoneal dialysis patient |
Primary outcome
To evaluate the use of the ultra sound and FAST scans in a simulation of a mass causality incident by paramedics for accuracy and speed
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.
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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.
James A Cusser, MD principal investigator
Ascension Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SonoSite Ultrasound in people with Mass Casualty, run by Ascension Health at 1 site in United States.
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 4 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 17 Aug 2012. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the use of the ultra sound and FAST scans in a simulation of a mass causality incident by paramedics for accuracy and speed (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2012.