HypotensionPhase 2NCT00256724
Efficacy Study of a Facemask Device to Treat Hypotension
A Phase 2 study testing Impedance Threshold Device in people with Hypotension, run by Advanced Circulatory Systems at 1 site in United States.
Trial summary
The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia. The cause of hypovolemia could be blood loss, sepsis, or dehydration. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypotension
- What is being tested?
- Impedance Threshold Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jan 2008
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conscious patient
- Systolic blood pressure < 95 mmHg
- Hypotension caused by blood loss, sepsis, or dehydration
Who cannot join
- Hypotension secondary to heart failure
- Complaints of chest pain
- History of heart failure
- Complaints of shortness of breath
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55404
About this study
Official title: Evaluation of an Inspiratory Impedance Threshold Device (ITD) in the Emergency Department for the Treatment of Hypotension
The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia. The cause of hypovolemia could be blood loss, sepsis, or dehydration.
Read the detailed description
The study is designed to test the hypothesis that use of the ITD will result in a rapid rise in blood pressure secondary to an increase in cardiac output. Either an active or sham ITD will be applied to hypotensive patients when initially presented to the emergency department with a systolic blood pressure of <95mmHg. The main endpoint of this study will be the rise in blood pressure over the first 10 minutes of use. Based upon pre-clinical studies as well as clinical studies performed to date, we hypothesize that use of the active ITD will result in a more rapid and higher blood pressure than the sham ITD. Multiple additional clinical parameters will also be compared between the two groups of patients.
- Conditions
- Hypotension
- Being tested
- Impedance Threshold Device, sham ITD
- Keywords
- hypotension, hypovolemia, dehydration, sepsis, blood loss
- Medical subject headings
- Hypotension, Hypovolemia, Dehydration, Sepsis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impedance Threshold DeviceDevice
Also called ResQGard
Active impedance threshold device
sham ITDDevice
sham impedance threshold device
| Study group | Role | What they receive |
|---|---|---|
| Sham ITD | Sham comparator | sham Impedance Threshold Device Receives: Device: sham ITD |
| active ITD | Active comparator | active impedance threshold device Receives: Device: Impedance Threshold Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline
Measured: every 2 minutes during 10 minutes of device use
Secondary outcomes (1)
Quantity of Fluid Administration
Measured: during 10 minutes of device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startJun 2005
- Primary completionJan 2008
- Study completionJan 2008
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Circulatory Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Keith Lurie, MD, Principal investigator, Advanced Circulatory Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256724
- Sponsor's protocol ID
- 43-0278-00
- Other IDs
- Contract W81XWH-04-C-0022
- Status last verified
- Jul 2013
- First submitted
- 18 Nov 2005
- Last updated
- 31 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Convertino VA, Cooke WH, Lurie KG. Inspiratory resistance as a potential treatment for orthostatic intolerance and hemorrhagic shock. Aviat Space Environ Med. 2005 Apr;76(4):319-25.
PubMed 15828629Convertino VA, Ratliff DA, Crissey J, Doerr DF, Idris AH, Lurie KG. Effects of inspiratory impedance on hemodynamic responses to a squat-stand test in human volunteers: implications for treatment of orthostatic hypotension. Eur J Appl Physiol. 2005 Jul;94(4):392-9. doi: 10.1007/s00421-005-1344-1. Epub 2005 Apr 28.
PubMed 15864634Convertino VA, Ratliff DA, Ryan KL, Doerr DF, Ludwig DA, Muniz GW, Britton DL, Clah SD, Fernald KB, Ruiz AF, Lurie KG, Idris AH. Hemodynamics associated with breathing through an inspiratory impedance threshold device in human volunteers. Crit Care Med. 2004 Sep;32(9 Suppl):S381-6. doi: 10.1097/01.ccm.0000134348.69165.15.
PubMed 15508665Smith SW, Parquette B, Lindstrom D, Metzger AK, Kopitzke J, Clinton J. An impedance threshold device increases blood pressure in hypotensive patients. J Emerg Med. 2011 Nov;41(5):549-58. doi: 10.1016/j.jemermed.2010.05.013. Epub 2010 Jul 15.
PubMed 20634018
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Inspiratory Impedance Threshold Device (ITD) in the Emergency Department for the Treatment of Hypotension
- ClinicalTrials.gov ID
- NCT00256724
- Acronym / sponsor ID
- 43-0278-00
- Conditions
- Hypotension
- Keywords
- hypotension, hypovolemia, dehydration, sepsis, blood loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Advanced Circulatory SystemsIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Jun 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Nov 2005 (estimated)
- Results
- Posted 18 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia. The cause of hypovolemia could be blood loss, sepsis, or dehydration.
Detailed description
The study is designed to test the hypothesis that use of the ITD will result in a rapid rise in blood pressure secondary to an increase in cardiac output. Either an active or sham ITD will be applied to hypotensive patients when initially presented to the emergency department with a systolic blood pressure of <95mmHg. The main endpoint of this study will be the rise in blood pressure over the first 10 minutes of use. Based upon pre-clinical studies as well as clinical studies performed to date, we hypothesize that use of the active ITD will result in a more rapid and higher blood pressure than the sham ITD. Multiple additional clinical parameters will also be compared between the two groups of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham ITD | Sham comparator | Device: sham ITDsham Impedance Threshold Device |
| active ITD | Active comparator | Device: Impedance Threshold Deviceactive impedance threshold device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Conscious patient
- Systolic blood pressure < 95 mmHg
- Hypotension caused by blood loss, sepsis, or dehydration
Key exclusion criteria (4 listed)
- Hypotension secondary to heart failure
- Complaints of chest pain
- History of heart failure
- Complaints of shortness of breath
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 |
|---|---|---|
| Impedance Threshold DeviceAlso: ResQGardActive impedance threshold device | Device | active ITD |
| sham ITDsham impedance threshold device | Device | Sham ITD |
Primary outcome
Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline
Time frame: every 2 minutes during 10 minutes of device use
1 secondary outcome
Quantity of Fluid Administration
Time frame: during 10 minutes of device use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15828629Convertino VA, Cooke WH, Lurie KG. Inspiratory resistance as a potential treatment for orthostatic intolerance and hemorrhagic shock. Aviat Space Environ Med. 2005 Apr;76(4):319-25.
- Background: PubMed 15864634Convertino VA, Ratliff DA, Crissey J, Doerr DF, Idris AH, Lurie KG. Effects of inspiratory impedance on hemodynamic responses to a squat-stand test in human volunteers: implications for treatment of orthostatic hypotension. Eur J Appl Physiol. 2005 Jul;94(4):392-9. doi: 10.1007/s00421-005-1344-1. Epub 2005 Apr 28.
- Background: PubMed 15508665Convertino VA, Ratliff DA, Ryan KL, Doerr DF, Ludwig DA, Muniz GW, Britton DL, Clah SD, Fernald KB, Ruiz AF, Lurie KG, Idris AH. Hemodynamics associated with breathing through an inspiratory impedance threshold device in human volunteers. Crit Care Med. 2004 Sep;32(9 Suppl):S381-6. doi: 10.1097/01.ccm.0000134348.69165.15.
- Results publication: PubMed 20634018Smith SW, Parquette B, Lindstrom D, Metzger AK, Kopitzke J, Clinton J. An impedance threshold device increases blood pressure in hypotensive patients. J Emerg Med. 2011 Nov;41(5):549-58. doi: 10.1016/j.jemermed.2010.05.013. Epub 2010 Jul 15.
- Advanced Circulatory Systems, Inc. home pageLink provided by the sponsor.
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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.
Keith Lurie, MD principal investigator
Advanced Circulatory Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Impedance Threshold Device in people with Hypotension, run by Advanced Circulatory Systems 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 3 inclusion and 4 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 31 Jul 2013. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 18 Jul 2013). 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?
Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline (time frame: every 2 minutes during 10 minutes of device use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00256724, which also lists 4 linked publications.
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 31 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.