ShockHEAvyHATNCT02177188
HEAVy HAT-HEAlthy Volunteers Heart to Arm Time. Haemorrhage Simulation Protocol in Healthy Volunteers
A study testing LBNP Lower Bodi Negative Pressure Chamber in people with Shock, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
In prehospital settings, hypovolemic shock diagnosis is based on Advanced Trauma Life Support (ATLS) shock classification. The most often used clinical signs are heart rate (HR), arterial blood pressure (BP), respiratory rate, neurologic status, diuresis, skin colour and temperature. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shock
- What is being tested?
- LBNP Lower Bodi Negative Pressure Chamber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Sep 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30 healthy volunteers with no assumption of coffee or any other substance with possible action on the autonomic nervous system.
Who cannot join
- age < 18 yrs,
- pregnancy,
- assumption of any drugs and existence of any disease,
- intake of any drug/substance with action on the autonomic nervous system during the previous 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HEAVy HAT-HEAlthy Volunteers Heart to Arm Time. Haemorrhage Simulation Protocol in Healthy Volunteers.
In prehospital settings, hypovolemic shock diagnosis is based on Advanced Trauma Life Support (ATLS) shock classification. The most often used clinical signs are heart rate (HR), arterial blood pressure (BP), respiratory rate, neurologic status, diuresis, skin colour and temperature. However, some of these signs, such as hypotension and tachycardia, lack specificity and sensitivity and do not occur early enough. Even with an early preload reduction, blood pressure can remain constant due to compensatory mechanisms, such as vasoconstriction and positive chronotropism. Tachycardia occurs earlier, but has poor specificity and sensitivity. A retrospective analysis of 25,287 trauma patients showed that among 489 patients presenting with systolic BP < 90 mmHg, only 65% had tachycardia (HR > 90 bpm), while 39% of patients with systolic BP > 120 mmHg were tachycardic, probably resulting from other stimuli influencing heart rate, such as pain, fear, circulating hormones and endogenous enkephalins. Therefore, it could be very useful to have an index that identifies initial volume variation, when physiological regulatory mechanisms are still effectively maintaining normal BP.
Pulse transit time (PTT) is the sum of pre-ejection period (PEP; the time interval between the onset of ventricular depolarization and ventricular ejection) and vascular transit time (VTT; the time it takes for the pulse wave to travel from the aortic valve to peripheral arteries). PEP and VTT variations depend on preload variation, and PTT increases with PEP, showing a linear correlation (R2 = 0.96). Chan et al. subjected 11 healthy volunteers to the head-up tilt test, and demonstrated that PEP increased and VTT decreased for increasing tilt angles from 0° to 80°, corresponding to light-moderate bleeding. They also observed early sympathetic activation, expressed by decreases of both RR interval (RR) and VTT, dampening the PTT increase, since PTT is influenced by both continuous PEP increase and progressive VTT decrease occurring during hypovolaemia.
Read more
Here the investigators describe a new index, called indexed Heart to Arm Time (iHAT). iHAT is the mPTT/RR ratio, where mPTT is a modified PTT, measured from the onset of ventricular depolarization (the 'R' wave of the ECG trace) to the systolic peak of the photoplethysmographic pulse oxymetry (PPG) waveform. mPTT is indexed to RR interval on ECG to counteract sympathetic activation that would dampen PEP increase and enhance VTT reduction, by means of positive inotropism and peripheral vasoconstriction, respectively. iHAT therefore increases during haemorrhage because of preload reduction and the consequent PEP increase and RR interval decrease. iHAT is expressed as the time percentage of the interbeat interval (RR) it takes to the PPG waveform to travel to peripheral arteries. In this study iHAT has been calculated as the average of beat-to-beat mPTT/RR ratios over 30 heart beats (corresponding to at least 2 breathing cycles) in order to minimize the effect of spontaneous breathing on preload, and thus on PEP and PTT.
In the present study, the investigators aimed to evaluate iHAT in a simulating model of hypovolaemia by using a Lower Body Negative Pressure (LBNP) chamber. LBNP chamber simulates haemorrhage by applying negative pressure to the lower limbs, thus giving an accurate model of hypovolemia. The LBNP chamber has been used for many years for research purposes, and in 2001 Convertino suggested it is a useful device to test severe haemorrhage-related hemodynamic responses. In fact, the induced volemic sequestration is an efficient technique to study physiological behaviours in humans.
The primary endpoint was to evaluate the use of the iHAT as a predictor of hypovolaemia. The secondary endpoint was to compare the specificity and sensitivity of the iHAT index compared to commonly used indexes (BP, HR). Furthermore, the investigators aimed to assess feasibility of Transthoracic echocardiography (TTE) evaluation of Cardiac Output (CO) in a haemorrhagic model and to evaluate CO changes with respect to measured hemodynamic variables.
TTE evaluation of CO is non invasive and comparable to thermodilution, and of possible use in an emergency setting.
- Conditions
- Shock
- Being tested
- LBNP Lower Bodi Negative Pressure Chamber
- Keywords
- Hypovolaemic shock, Monitoring, Haemorrhage, Transthoracic Echocardiography
- Medical subject headings
- Shock, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBNP Lower Bodi Negative Pressure ChamberDevice
| Study group | Role | What they receive |
|---|---|---|
| Haemorrhage simulation | Experimental | Not described Receives: Device: LBNP Lower Bodi Negative Pressure Chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
iHAT validation as a bleeding predictor in a simulated and controlled haemorrhage model (Lower Body Negative Pressure chamber, LBNP)
Measured: Progressive lower body negative pressure (LBNP) was applied in 5-min stages until the onset of impending cardiovascular collapse.
Secondary outcomes (1)
Change from baseline in CO evaluated by Transthoracic echocardiography (TTE) during an haemorrhagic model
Measured: Progressive lower body negative pressure (LBNP) was applied in 5-min stages until the onset of impending cardiovascular collapse.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startApr 2012
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ShockStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177188
- Sponsor's protocol ID
- HHAT2012
- Acronym
- HEAvyHAT
- Status last verified
- Jun 2014
- First submitted
- 1 Mar 2013
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan GS, Middleton PM, Celler BG, Wang L, Lovell NH. Change in pulse transit time and pre-ejection period during head-up tilt-induced progressive central hypovolaemia. J Clin Monit Comput. 2007 Oct;21(5):283-93. doi: 10.1007/s10877-007-9086-8. Epub 2007 Aug 16.
PubMed 17701385Esch BT, Scott JM, Warburton DE. Construction of a lower body negative pressure chamber. Adv Physiol Educ. 2007 Mar;31(1):76-81. doi: 10.1152/advan.00009.2006.
PubMed 17327587Convertino VA; New Collective Author. Lower body negative pressure as a tool for research in aerospace physiology and military medicine. J Gravit Physiol. 2001 Dec;8(2):1-14.
PubMed 12365445
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEAVy HAT-HEAlthy Volunteers Heart to Arm Time. Haemorrhage Simulation Protocol in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02177188
- Acronym / sponsor ID
- HEAvyHAT / HHAT2012
- Conditions
- Shock
- Keywords
- Hypovolaemic shock, Monitoring, Haemorrhage, Transthoracic Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 Jun 2014 (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.
In prehospital settings, hypovolemic shock diagnosis is based on Advanced Trauma Life Support (ATLS) shock classification. The most often used clinical signs are heart rate (HR), arterial blood pressure (BP), respiratory rate, neurologic status, diuresis, skin colour and temperature. However, some of these signs, such as hypotension and tachycardia, lack specificity and sensitivity and do not occur early enough. Even with an early preload reduction, blood pressure can remain constant due to compensatory mechanisms, such as vasoconstriction and positive chronotropism. Tachycardia occurs earlier, but has poor specificity and sensitivity. A retrospective analysis of 25,287 trauma patients showed that among 489 patients presenting with systolic BP < 90 mmHg, only 65% had tachycardia (HR > 90 bpm), while 39% of patients with systolic BP > 120 mmHg were tachycardic, probably resulting from other stimuli influencing heart rate, such as pain, fear, circulating hormones and endogenous enkephalins. Therefore, it could be very useful to have an index that identifies initial volume variation, when physiological regulatory mechanisms are still effectively maintaining normal BP.
Pulse transit time (PTT) is the sum of pre-ejection period (PEP; the time interval between the onset of ventricular depolarization and ventricular ejection) and vascular transit time (VTT; the time it takes for the pulse wave to travel from the aortic valve to peripheral arteries). PEP and VTT variations depend on preload variation, and PTT increases with PEP, showing a linear correlation (R2 = 0.96). Chan et al. subjected 11 healthy volunteers to the head-up tilt test, and demonstrated that PEP increased and VTT decreased for increasing tilt angles from 0° to 80°, corresponding to light-moderate bleeding. They also observed early sympathetic activation, expressed by decreases of both RR interval (RR) and VTT, dampening the PTT increase, since PTT is influenced by both continuous PEP increase and progressive VTT decrease occurring during hypovolaemia.
Here the investigators describe a new index, called indexed Heart to Arm Time (iHAT). iHAT is the mPTT/RR ratio, where mPTT is a modified PTT, measured from the onset of ventricular depolarization (the 'R' wave of the ECG trace) to the systolic peak of the photoplethysmographic pulse oxymetry (PPG) waveform. mPTT is indexed to RR interval on ECG to counteract sympathetic activation that would dampen PEP increase and enhance VTT reduction, by means of positive inotropism and peripheral vasoconstriction, respectively. iHAT therefore increases during haemorrhage because of preload reduction and the consequent PEP increase and RR interval decrease. iHAT is expressed as the time percentage of the interbeat interval (RR) it takes to the PPG waveform to travel to peripheral arteries. In this study iHAT has been calculated as the average of beat-to-beat mPTT/RR ratios over 30 heart beats (corresponding to at least 2 breathing cycles) in order to minimize the effect of spontaneous breathing on preload, and thus on PEP and PTT.
In the present study, the investigators aimed to evaluate iHAT in a simulating model of hypovolaemia by using a Lower Body Negative Pressure (LBNP) chamber. LBNP chamber simulates haemorrhage by applying negative pressure to the lower limbs, thus giving an accurate model of hypovolemia. The LBNP chamber has been used for many years for research purposes, and in 2001 Convertino suggested it is a useful device to test severe haemorrhage-related hemodynamic responses. In fact, the induced volemic sequestration is an efficient technique to study physiological behaviours in humans.
The primary endpoint was to evaluate the use of the iHAT as a predictor of hypovolaemia. The secondary endpoint was to compare the specificity and sensitivity of the iHAT index compared to commonly used indexes (BP, HR). Furthermore, the investigators aimed to assess feasibility of Transthoracic echocardiography (TTE) evaluation of Cardiac Output (CO) in a haemorrhagic model and to evaluate CO changes with respect to measured hemodynamic variables.
TTE evaluation of CO is non invasive and comparable to thermodilution, and of possible use in an emergency setting.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Haemorrhage simulation | Experimental | Device: LBNP Lower Bodi Negative Pressure Chamber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 30 healthy volunteers with no assumption of coffee or any other substance with possible action on the autonomic nervous system.
Key exclusion criteria (4 listed)
- age < 18 yrs,
- pregnancy,
- assumption of any drugs and existence of any disease,
- intake of any drug/substance with action on the autonomic nervous system during the previous 24 hours.
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 |
|---|---|---|
| LBNP Lower Bodi Negative Pressure Chamber | Device | Haemorrhage simulation |
Primary outcome
iHAT validation as a bleeding predictor in a simulated and controlled haemorrhage model (Lower Body Negative Pressure chamber, LBNP)
Time frame: Progressive lower body negative pressure (LBNP) was applied in 5-min stages until the onset of impending cardiovascular collapse.
1 secondary outcome
Change from baseline in CO evaluated by Transthoracic echocardiography (TTE) during an haemorrhagic model
Time frame: Progressive lower body negative pressure (LBNP) was applied in 5-min stages until the onset of impending cardiovascular collapse.
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 27 Jun 2014.
- Background: PubMed 17701385Chan GS, Middleton PM, Celler BG, Wang L, Lovell NH. Change in pulse transit time and pre-ejection period during head-up tilt-induced progressive central hypovolaemia. J Clin Monit Comput. 2007 Oct;21(5):283-93. doi: 10.1007/s10877-007-9086-8. Epub 2007 Aug 16.
- Background: PubMed 17327587Esch BT, Scott JM, Warburton DE. Construction of a lower body negative pressure chamber. Adv Physiol Educ. 2007 Mar;31(1):76-81. doi: 10.1152/advan.00009.2006.
- Background: PubMed 12365445Convertino VA; New Collective Author. Lower body negative pressure as a tool for research in aerospace physiology and military medicine. J Gravit Physiol. 2001 Dec;8(2):1-14.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LBNP Lower Bodi Negative Pressure Chamber in people with Shock, run by University of Milano Bicocca at 1 site in Italy.
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 1 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 27 Jun 2014. 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 Italy. 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?
iHAT validation as a bleeding predictor in a simulated and controlled haemorrhage model (Lower Body Negative Pressure chamber, LBNP) (time frame: Progressive lower body negative pressure (LBNP) was applied in 5-min stages until the onset of impending cardiovascular collapse.). 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 NCT02177188, which also lists 3 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 27 Jun 2014.