HemorrhageNCT01935427
Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume
An observational study of Hemorrhage, run by Flashback Technologies at 1 site in United States.
Trial summary
This study is designed to validate implementation of the CRI algorithm in the CypherOx CRI system. Healthy human subjects will undergo progressive reduction in central blood volume to the point of hemodynamic instability (defined by a precipitous fall in systolic blood pressure (SBP) below 70 mmHg and/or voluntary… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2013
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy non-pregnant volunteers with no cardiovascular disease or other health issues.
Who may be able to join
- Healthy nonsmoking normotensive (<140/90) males or females.
- Age 18 to 55 yr.
- Normal clinical results from a Medical History and Physical form DD 2807-1
- Military or civilian.
- Documentation of a negative pregnancy test within 24 hours prior to each study period, if necessary.
- Not obese, as defined by body mass index (BMI) < 30, unless individual is athletic (BMI may not be the best method of assessing obesity in athletic individuals). BMI is calculated as the weight in kilograms divided by the square of the height in meters.
Who cannot join
- (a) Age <18 and >55 years.
- Individuals taking prescription drugs, non-prescription drugs or herbal medicines known to alter autonomic function unless cleared by the Medical Screener.
- Subjects using prescription medications within 30 days before initiation of the experiments unless cleared by the Medical Screener.
- Subjects with a history of alcohol or drug abuse which inhibits the subject's ability to complete this study.
- Smokers.
- Subjects with signs of cardiovascular abnormalities (e.g., hypertension (> 140/90), autonomic dysfunction (Shy-Drager Syndrome, Bradbury-Eggleston syndrome, sinus arrhythmia, idiopathic orthostatic hypotension), fainting disorder, etc.).
Show all 12Show fewer
- Subjects with respiratory illnesses (e.g., asthma, Chronic Obstructive Pulmonary Disease, Reactive Airway Disease, etc.).
- Subjects with a history of anaphylaxis.
- Subjects with allergies to medications not cleared by the Medical Screener. Individuals reporting a history of pre-syncopal/syncopal episodes or orthostatic hypotension.
- Subjects with a history or family history of abnormal blood clotting, clots in deep veins in the legs or pelvis, or blood clots to the lungs.
- Individuals taking prescription medications for hypertension (high blood pressure). (l) Individuals with known or suspected abdominal hernias
- Pregnancy, trying to become pregnant, or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Institute of Surgical Research
San Antonio, Texas, 78234-7767
About this study
This study is designed to validate implementation of the CRI algorithm in the CypherOx CRI system.
Healthy human subjects will undergo progressive reduction in central blood volume to the point of hemodynamic instability (defined by a precipitous fall in systolic blood pressure (SBP) below 70 mmHg and/or voluntary subject termination due to discomfort (such as sweating, nausea, or dizziness) to validate the following hypotheses:
The CypherOx CRI system will A. Trend intravascular volume changes (hemorrhage) B. Trend stroke volume changes and C. The CRI trend value is not relative to an initial CRI reading, instead it is an actual CRI trend value that does not require calibration or being placed during normal physiological conditions.
Read the detailed description
Hemorrhagic shock is a leading cause of death in both civilian and battlefield trauma. Currently available medical monitors provide the capabilities to measure standard vital signs that are often imprecise, subjective, intermittent and inconsistent. More importantly, the appearance of hypotension and other signs and symptoms of shock represent a point in time when it may be too late to apply effective lifesaving interventions. Understanding the physiological signals that provide the best indicators of blood volume loss and impending circulatory failure is critical to bridging the capability gap of identifying the need for early intervention. Under a previous BAMC IRB-approved protocol, we used lower body negative pressure (LBNP) as an experimental model of central hypovolemia to simulate progressive blood loss that results in hemodynamic instability (e.g., hypotension, tachycardia, presyncopal symptoms) in conscious, healthy human subjects. From data collected within this original protocol, we now understand that arterial waveforms (either blood pressure or pulse oximetry) are important variables associated with hypovolemia. Feature extraction and machine learning techniques were applied to these previously collected data and an algorithm was developed called Compensatory Reserve Index (CRI) which was designed to reflect progressive blood loss and decreasing stroke volume. This algorithm was installed in a pulse oximeter in which the photo-plethysmographic waveform (PPG) was used to calculate the CRI. Using this CRI Pulse oximeter, a pretrial study of 24 subjects indicated a high correlation in trending of blood volume loss (DOD study at Mayo Clinic) and a mean correlation of 0.96 when comparing CRI to stroke volume (LBNP at AISR Laboratory). The work proposed herein will validate those findings. During each experiment each test subject will wear 4 FDA cleared pulse oximeters which transmit PPG data to an off-the-shelf handheld tablet (meets military specs) which will calculate and display the CRI value. The subjects will also wear 2 FDA cleared Nexfin hemodynamic monitors that display stroke volume. LBNP will be used to produce progressive central hypovolemia in healthy human subjects until the point of hemodynamic decompensation (presyncope). This approach will validate the correlation of CRI to stroke volume.
- Conditions
- Hemorrhage
- Keywords
- Pulse Oximeter, Stroke Volume, Hemorrhagic shock, Compensatory Reserve Index
- Medical subject headings
- Hemorrhage, Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Volunteer test subjects | Healthy volunteer with no cardiovascular disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
15 subjects must complete the LBNP trial
15 subjects must complete the LBNP trial to 70mmHg negative pressure
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flashback Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victor A Convertino, Ph.D., Principal investigator, US Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935427
- Sponsor's protocol ID
- CRIV2
- Status last verified
- Mar 2015
- First submitted
- 28 Aug 2013
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume
- ClinicalTrials.gov ID
- NCT01935427
- Acronym / sponsor ID
- CRIV2
- Conditions
- Hemorrhage
- Keywords
- Pulse Oximeter, Stroke Volume, Hemorrhagic shock, Compensatory Reserve Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Flashback TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Sep 2013 (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 is designed to validate implementation of the CRI algorithm in the CypherOx CRI system.
Healthy human subjects will undergo progressive reduction in central blood volume to the point of hemodynamic instability (defined by a precipitous fall in systolic blood pressure (SBP) below 70 mmHg and/or voluntary subject termination due to discomfort (such as sweating, nausea, or dizziness) to validate the following hypotheses:
The CypherOx CRI system will A. Trend intravascular volume changes (hemorrhage) B. Trend stroke volume changes and C. The CRI trend value is not relative to an initial CRI reading, instead it is an actual CRI trend value that does not require calibration or being placed during normal physiological conditions.
Detailed description
Hemorrhagic shock is a leading cause of death in both civilian and battlefield trauma. Currently available medical monitors provide the capabilities to measure standard vital signs that are often imprecise, subjective, intermittent and inconsistent. More importantly, the appearance of hypotension and other signs and symptoms of shock represent a point in time when it may be too late to apply effective lifesaving interventions. Understanding the physiological signals that provide the best indicators of blood volume loss and impending circulatory failure is critical to bridging the capability gap of identifying the need for early intervention. Under a previous BAMC IRB-approved protocol, we used lower body negative pressure (LBNP) as an experimental model of central hypovolemia to simulate progressive blood loss that results in hemodynamic instability (e.g., hypotension, tachycardia, presyncopal symptoms) in conscious, healthy human subjects. From data collected within this original protocol, we now understand that arterial waveforms (either blood pressure or pulse oximetry) are important variables associated with hypovolemia. Feature extraction and machine learning techniques were applied to these previously collected data and an algorithm was developed called Compensatory Reserve Index (CRI) which was designed to reflect progressive blood loss and decreasing stroke volume. This algorithm was installed in a pulse oximeter in which the photo-plethysmographic waveform (PPG) was used to calculate the CRI. Using this CRI Pulse oximeter, a pretrial study of 24 subjects indicated a high correlation in trending of blood volume loss (DOD study at Mayo Clinic) and a mean correlation of 0.96 when comparing CRI to stroke volume (LBNP at AISR Laboratory). The work proposed herein will validate those findings. During each experiment each test subject will wear 4 FDA cleared pulse oximeters which transmit PPG data to an off-the-shelf handheld tablet (meets military specs) which will calculate and display the CRI value. The subjects will also wear 2 FDA cleared Nexfin hemodynamic monitors that display stroke volume. LBNP will be used to produce progressive central hypovolemia in healthy human subjects until the point of hemodynamic decompensation (presyncope). This approach will validate the correlation of CRI to stroke volume.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteer test subjects | – | –Healthy volunteer with no cardiovascular disease |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy non-pregnant volunteers with no cardiovascular disease or other health issues.
Key inclusion criteria (6 listed)
- Healthy nonsmoking normotensive (<140/90) males or females.
- Age 18 to 55 yr.
- Normal clinical results from a Medical History and Physical form DD 2807-1
- Military or civilian.
- Documentation of a negative pregnancy test within 24 hours prior to each study period, if necessary.
Key exclusion criteria (12 listed)
- (a) Age <18 and >55 years.
- Individuals taking prescription drugs, non-prescription drugs or herbal medicines known to alter autonomic function unless cleared by the Medical Screener.
- Subjects using prescription medications within 30 days before initiation of the experiments unless cleared by the Medical Screener.
- Subjects with a history of alcohol or drug abuse which inhibits the subject's ability to complete this study.
- Smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
15 subjects must complete the LBNP trial
Time frame: Up to 4 months
15 subjects must complete the LBNP trial to 70mmHg negative pressure
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 6 Mar 2015.
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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.
Victor A Convertino, Ph.D. 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?
An observational study of Hemorrhage, run by Flashback Technologies 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 6 inclusion and 12 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 6 Mar 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 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?
15 subjects must complete the LBNP trial (time frame: Up to 4 months). 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 6 Mar 2015.