Orthostatic HypotensionNCT00137319
Impedance Threshold Device Tilt Study
A study testing Impedance threshold device in people with Orthostatic Hypotension, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial summary
This study will see if a special piece of equipment can help burn patients who have been in bed for a long time to get out of bed without feeling dizzy or faint. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- Impedance threshold device
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jun 2006
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Military or civilian males or females between the ages of 18-65 years
- Burn injury with at least one unburned finger for Portapres measurement
- Minimum of 96 hours bedrest or physician directive to tilt
Who cannot join
- Age < 18 and > 65 years
- Facial burns when application of ITD device would cause further trauma
- Medical monitoring devices that preclude the use of the ITD
- Signs of cardiac abnormalities, autonomic dysfunction
- Chronic obstructive pulmonary disease (COPD), or any other respiratory limitations (ventilator dependent, intubated, tracheostomy) limiting use of ITD
- History of pre-syncopal/syncopal episodes or orthostatic hypotension
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- History of atherosclerotic coronary heart disease
- Patients taking any kind of cardiovascular pressor medications
- Inability to obtain a Portapres pulse wave validated by blood pressure cuff with +/- 5mmHg diastolic blood pressure
- Unable to provide informed consent for self
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
About this study
Official title: An Evaluation of an Impedance Threshold Device (ITD) to Improve Hemodynamic Function During Orthostatic Challenge in Burn Patients
This study will see if a special piece of equipment can help burn patients who have been in bed for a long time to get out of bed without feeling dizzy or faint.
Read the detailed description
To measure stroke volume, cardiac output, arterial blood pressure and cerebral blood flow velocity in human patients while they undergo exposure to head-up tilt that is designed to test their tolerance to an orthostatic challenge.
- Conditions
- Orthostatic Hypotension
- Being tested
- Impedance threshold device
- Keywords
- inspiratory impedance threshold device, blood pressure regulation, head-up tilt test, tilt table testing, burn injury, Burns
- Medical subject headings
- Hypotension, Orthostatic, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impedance threshold deviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startOct 2004
- Study completionJun 2006
Why it stopped: Aims of the study re-evaluated, did not justify allocation of resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthostatic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Investigators
- Travis Hedman, MPT, CPT, SP, Principal investigator, US Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137319
- Sponsor's protocol ID
- H-04-016
- Status last verified
- Jul 2015
- First submitted
- 25 Aug 2005
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Convertino VA, Idris A, Ratliff D, Ryan K, Doerr D, Lurie K. Use of an inspiratory impedance threshold valve increases cardiac output in human volunteers. Crit. Care Med. 30:A66, 2003
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of an Impedance Threshold Device (ITD) to Improve Hemodynamic Function During Orthostatic Challenge in Burn Patients
- ClinicalTrials.gov ID
- NCT00137319
- Acronym / sponsor ID
- H-04-016
- Conditions
- Orthostatic Hypotension
- Keywords
- inspiratory impedance threshold device, blood pressure regulation, head-up tilt test, tilt table testing, burn injury, Burns
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Aims of the study re-evaluated, did not justify allocation of resources.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Oct 2004
- Study completion
- Jun 2006 (actual)
- First posted
- 29 Aug 2005 (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.
This study will see if a special piece of equipment can help burn patients who have been in bed for a long time to get out of bed without feeling dizzy or faint.
Detailed description
To measure stroke volume, cardiac output, arterial blood pressure and cerebral blood flow velocity in human patients while they undergo exposure to head-up tilt that is designed to test their tolerance to an orthostatic challenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Military or civilian males or females between the ages of 18-65 years
- Burn injury with at least one unburned finger for Portapres measurement
- Minimum of 96 hours bedrest or physician directive to tilt
Key exclusion criteria (10 listed)
- Age < 18 and > 65 years
- Facial burns when application of ITD device would cause further trauma
- Medical monitoring devices that preclude the use of the ITD
- Signs of cardiac abnormalities, autonomic dysfunction
- Chronic obstructive pulmonary disease (COPD), or any other respiratory limitations (ventilator dependent, intubated, tracheostomy) limiting use of ITD
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 device | Device | – |
Primary outcome
Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension.
Time frame: 1 hour
Results and safety
The study was stopped early (reason given: Aims of the study re-evaluated, did not justify allocation of resources.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- BackgroundConvertino VA, Idris A, Ratliff D, Ryan K, Doerr D, Lurie K. Use of an inspiratory impedance threshold valve increases cardiac output in human volunteers. Crit. Care Med. 30:A66, 2003
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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.
Travis Hedman, MPT, CPT, SP principal investigator
US Army Institute of Surgical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impedance threshold device in people with Orthostatic Hypotension, run by United States Army Institute of Surgical Research 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 10 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: stopped early, as of the sponsor's last update on 22 Jul 2015. 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 was stopped early (reason given: Aims of the study re-evaluated, did not justify allocation of resources.). Results are not available in the source record.
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?
Inspiratory impedance during passive upright tilt will prevent orthostatic hypotension. (time frame: 1 hour). 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 NCT00137319, which also lists 1 linked publication.
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 22 Jul 2015.