Acute HypotensionPhase 4NCT01780350
Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department
A Phase 4 study testing ResQGARD ITD in people with Acute Hypotension, run by Advanced Circulatory Systems.
Trial summary
This study is attached to a comprehensive quality assurance/quality improvement (QA/QI) program conducted by the Office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an FDA approved Impedance Threshold Device (ITD) device in a large… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypotension
- What is being tested?
- ResQGARD ITD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Oct 2012
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults between the ages of 18-120 years
- presenting to EMS with or development of Hypotension during EMS interaction
- treated by EMS with the ITD
Who cannot join
- pediatric patients
- patients that do not present with or develop hypotension
- patients who the ITD will not form a secure seal due to anatomical abnormalities
About this study
This study is attached to a comprehensive quality assurance/quality improvement (QA/QI) program conducted by the Office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an FDA approved Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS) system. The cohort will comprise a convenience sample of patients that are being treated by EMS for a hypotensive emergency.
- Conditions
- Acute Hypotension
- Being tested
- ResQGARD ITD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResQGARD ITDDevice
Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.
| Study group | Role | What they receive |
|---|---|---|
| ResQGARD ITD | Experimental | Subjects receive a ResQGARD ITD. Receives: Device: ResQGARD ITD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure From Baseline (Before ITD Use)
Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.
Measured: During device use, up to 1 hour
Secondary outcomes (1)
Tolerability
Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device.
Measured: Duration of device use, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionOct 2012
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 Acute HypotensionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Circulatory Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780350
- Sponsor's protocol ID
- W81XWH-BAA-11-1
- Status last verified
- Feb 2015
- First submitted
- 19 Jul 2012
- Last updated
- 27 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department
- ClinicalTrials.gov ID
- NCT01780350
- Acronym / sponsor ID
- W81XWH-BAA-11-1
- Conditions
- Acute Hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Advanced Circulatory SystemsIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Posted 27 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is attached to a comprehensive quality assurance/quality improvement (QA/QI) program conducted by the Office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an FDA approved Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS) system. The cohort will comprise a convenience sample of patients that are being treated by EMS for a hypotensive emergency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ResQGARD ITD | Experimental | Device: ResQGARD ITDSubjects receive a ResQGARD ITD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults between the ages of 18-120 years
- presenting to EMS with or development of Hypotension during EMS interaction
- treated by EMS with the ITD
Key exclusion criteria (3 listed)
- pediatric patients
- patients that do not present with or develop hypotension
- patients who the ITD will not form a secure seal due to anatomical abnormalities
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 |
|---|---|---|
| ResQGARD ITDPatients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel. | Device | ResQGARD ITD |
Primary outcome
Change in Systolic Blood Pressure From Baseline (Before ITD Use)
Time frame: During device use, up to 1 hour
Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.
1 secondary outcome
Tolerability
Time frame: Duration of device use, up to 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ResQGARD ITD in people with Acute Hypotension, run by Advanced Circulatory Systems.
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 3 inclusion and 3 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 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2015). 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 Systolic Blood Pressure From Baseline (Before ITD Use) (time frame: During device use, up to 1 hour). 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 27 Feb 2015.