Health, SubjectivePlethysmoNCT03481855
Plethysmographic Pulse-contour and Pulse-wave-transit-times for Haemodynamic Evaluation in Bleeding Simulation
An observational study of Health, Subjective, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The evaluation of haemodynamic changes is still challenging in clinically relevant situations (e.g. in bleeding, septic and postoperative patients) with the conventional monitoring routinely used including heart rate and mean arterial pressure. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Health, Subjective
- What is being tested?
- Lower-body-low-pressure chamber
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 6 Mar 2018to 11 Apr 2018
- How long will I take part?
- 1 Day
- 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 40 years
- Men only
- Adult
Study population: Healthy volunteers
Who may be able to join
- Offered patient information and written informed consent
- Existence of valid health insurance
- Male gender
Who cannot join
- Patients aged less than 18 years or more than 40 years
- Inability of German language use
- Lacking willingness to save and hand out data within the study
- Evidence of a chronic disease (cardio-vascular, renal, pulmonary, neurological, metabolic, gastro-intestinal)
- Chronic medication
- Signs of a reduced cardiorespiratory capacity
Show all 13Show fewer
- Signs of an acute illness
- Participation in a prospective intervention trial during the study period
- Anamnestic hints for syncope or disposition to hypotension
- Signs of arterial hypertension
- Signs of inguinal hernia
- Relevant pathologies in the baseline examination of the transthoracic echocardiography
- For the bio-impedance measurements: heart defibrillator
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin Berlin, Germany
Berlin, 13353
About this study
The evaluation of haemodynamic changes is still challenging in clinically relevant situations (e.g. in bleeding, septic and postoperative patients) with the conventional monitoring routinely used including heart rate and mean arterial pressure. If the arterial pressure drops and the heart increases, the haemodynamic state is already decompensated and a therapy is at risk being indicated too late.
Prior to decompensation - still in the state of compensated shock - it would be desirable to detect the shock already. The compensated shock is characterized by an occult drop of cardiac output and a hypoperfusion of vital organs like e.g. the splanchnic region. Due to these pathophysiological characteristics, a therapy would be indicated already in this stadium of shock progression.
Read more
The available monitoring tools to detect compensated shock are on the one hand side invasive (intravascular catheter), cost-intensive (cost of the catheter systems), or need extensive training (echocardiography). Consequently, the implementation of advanced haemodynamic monitoring is still low despite the high clinical relevance for the patients.
It is the goal of this project to evaluate in healthy volunteers the routinely implemented technology of photo-plethysmography in its ability to detect haemodynamic changes by extended signal analysis of the pulse-contour and the pulse-wave-transit-times in relation to the gold-standard echocardiography.
Secondary goal of this study is to analyse the physiological and haemodynamic changes during progressive central hypovolaemia displayed by non-invasive or minimal-invasive monitoring devices and associate the changes to each other.
- Conditions
- Health, Subjective
- Being tested
- Lower-body-low-pressure chamber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower-body-low-pressure chamberDevice
The lower-body-low-pressure chamber administers a negative pressure to the lower part of the body (below the waist) to induce a central hypovolaemia by pooling of blood in the legs according to Tymko, M. FACETS, Bd. 1, Nr. 1, S. 225-244, März 2017 and Esch, B.T.A. et al. AJP Adv. Physiol. Educ., Bd. 31, Nr. 1, S. 76-81, März 2007.
| Study group | Role | What they receive |
|---|---|---|
| Progressive bleeding simulation | The study intervention by a lower-body-low-pressure chamber is performed in this group of healthy volunteers with progressive increase of negative pressure by a step-wise approach (-15mmHg, -30mmHg, -45mmHg). Receives: Device: Lower-body-low-pressure chamber | |
| Prolonged bleeding simulation | The study intervention by a lower-body-low-pressure chamber is performed in this group of healthy volunteers with prolonged exposure to a negative pressure of -15mmHg. Receives: Device: Lower-body-low-pressure chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the pulse-contour-analysis of the plethysmographic signal
The pulse-contour of the plethysmographic signal will be analyzed to detect morphological changes over time in relation to the initial baseline recording
Measured: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Changes the pulse-wave-transit-times of the plethysmographic signal
The pulse-wave-transit-times of the plethysmographic signal will be analyzed to detect changes over time in relation to the initial baseline recording
Measured: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Secondary outcomes (16)
Arterial blood pressure
Arterial blood pressure determined by non-invasive monitoring
Measured: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Heart rate
Heart rate determined by non-invasive monitoring
Measured: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Echocardiographic parameter to determine the cardiac performance of the left ventricle
The performance of the left ventricle will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology
Measured: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Echocardiographic parameter to determine the cardiac performance of the left atrium
The performance of the left atrium will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology
Measured: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Echocardiographic parameter to determine the cardiac performance of the right ventricle
The performance of the right ventricle will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology
Measured: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Echocardiographic parameter to determine the cardiac performance of the right atrium
The performance of the right atrium will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology
Measured: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Echocardiographic parameter to analyze the vena cava inferior
The analysis will be assessed by a subcostal approach by transthoracic echocardiography
Measured: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Heart rate variability
Heart rate variability calculated from raw biosignals Bioelectrical signals by standardized analysis algorithms
Measured: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Haemodynamic parameter of the bio-impedance monitoring
The parameter will be determined by the electrical cardiometry/bio-impedance monitoring device of Osypka Medical
Measured: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Shock indices of the bio-impedance monitoring
The parameter will be determined by the electrical cardiometry/bio-impedance monitoring device of Osypka Medical
Measured: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Heart sounds
Heart sounds measured by vibration sensors
Measured: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Tonometric arterial blood pressure
Tonometric arterial blood pressure measured by applanation tonometer
Measured: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Haemodynamic parameter of the tonometric pulse-contour method
The parameter will be determined by the non-invasive monitoring device Finapress
Measured: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Mean systemic filling pressure
The parameters describing the characteristics of the venous return determined by the stop-flow method
Measured: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Questionnaire regarding alimentation
The questionnaire directs to characterize the intake of fluid and solid alimentation prior to the study protocol
Measured: Immediately prior to the start of the study protocol
Bio-impedance analysis of the body fluid
The bio-impedance analysis of the body fluid directs to determine the water content of the body
Measured: Immediately prior to the start of the study protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start6 Mar 2018
- Primary completion11 Apr 2018
- Study completion11 Apr 2018
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 Health, SubjectiveStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Berlin
- Responsible party
- Principal investigator, Aarne Feldheiser, Charite University, Berlin, Germany
- Investigators
- Aarne Feldheiser, MD, PhD, Principal investigator, Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin Berlin, Germany, 13353 Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481855
- Sponsor's protocol ID
- EA1/249/17
- Acronym
- Plethysmo
- Status last verified
- Sep 2018
- First submitted
- 5 Mar 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feldheiser A, Juhl-Olsen P, Nordine M, Stetzuhn M, Wiegank L, Knebel F, Treskatsch S, Berger C. A comprehensive echocardiographic analysis during simulated hypovolaemia: An observational study. Eur J Anaesthesiol. 2023 Aug 1;40(8):578-586. doi: 10.1097/EJA.0000000000001863. Epub 2023 Jun 1.
PubMed 37265333
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plethysmographic Pulse-contour and Pulse-wave-transit-times for Haemodynamic Evaluation in Bleeding Simulation
- ClinicalTrials.gov ID
- NCT03481855
- Acronym / sponsor ID
- Plethysmo / EA1/249/17
- Conditions
- Health, Subjective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Technische Universität Berlin
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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.
The evaluation of haemodynamic changes is still challenging in clinically relevant situations (e.g. in bleeding, septic and postoperative patients) with the conventional monitoring routinely used including heart rate and mean arterial pressure. If the arterial pressure drops and the heart increases, the haemodynamic state is already decompensated and a therapy is at risk being indicated too late.
Prior to decompensation - still in the state of compensated shock - it would be desirable to detect the shock already. The compensated shock is characterized by an occult drop of cardiac output and a hypoperfusion of vital organs like e.g. the splanchnic region. Due to these pathophysiological characteristics, a therapy would be indicated already in this stadium of shock progression.
The available monitoring tools to detect compensated shock are on the one hand side invasive (intravascular catheter), cost-intensive (cost of the catheter systems), or need extensive training (echocardiography). Consequently, the implementation of advanced haemodynamic monitoring is still low despite the high clinical relevance for the patients.
It is the goal of this project to evaluate in healthy volunteers the routinely implemented technology of photo-plethysmography in its ability to detect haemodynamic changes by extended signal analysis of the pulse-contour and the pulse-wave-transit-times in relation to the gold-standard echocardiography.
Secondary goal of this study is to analyse the physiological and haemodynamic changes during progressive central hypovolaemia displayed by non-invasive or minimal-invasive monitoring devices and associate the changes to each other.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive bleeding simulation | – | Device: Lower-body-low-pressure chamberThe study intervention by a lower-body-low-pressure chamber is performed in this group of healthy volunteers with progressive increase of negative pressure by a step-wise approach (-15mmHg, -30mmHg, -45mmHg). |
| Prolonged bleeding simulation | – | Device: Lower-body-low-pressure chamberThe study intervention by a lower-body-low-pressure chamber is performed in this group of healthy volunteers with prolonged exposure to a negative pressure of -15mmHg. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Offered patient information and written informed consent
- Existence of valid health insurance
- Male gender
Key exclusion criteria (13 listed)
- Patients aged less than 18 years or more than 40 years
- Inability of German language use
- Lacking willingness to save and hand out data within the study
- Evidence of a chronic disease (cardio-vascular, renal, pulmonary, neurological, metabolic, gastro-intestinal)
- Chronic medication
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 |
|---|---|---|
| Lower-body-low-pressure chamberThe lower-body-low-pressure chamber administers a negative pressure to the lower part of the body (below the waist) to induce a central hypovolaemia by pooling of blood in the legs according to Tymko, M. FACETS, Bd. 1, Nr. 1, S. 225-244, März 2017 and Esch, B.T.A. et al. AJP Adv. Physiol. Educ., Bd. 31, Nr. 1, S. 76-81, März 2007. | Device | Progressive bleeding simulation, Prolonged bleeding simulation |
Primary outcome
Changes in the pulse-contour-analysis of the plethysmographic signal
Time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
The pulse-contour of the plethysmographic signal will be analyzed to detect morphological changes over time in relation to the initial baseline recording
Changes the pulse-wave-transit-times of the plethysmographic signal
Time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
The pulse-wave-transit-times of the plethysmographic signal will be analyzed to detect changes over time in relation to the initial baseline recording
16 secondary outcomes
Arterial blood pressure
Time frame: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Heart rate
Time frame: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Echocardiographic parameter to determine the cardiac performance of the left ventricle
Time frame: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Echocardiographic parameter to determine the cardiac performance of the left atrium
Time frame: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Echocardiographic parameter to determine the cardiac performance of the right ventricle
Time frame: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Echocardiographic parameter to determine the cardiac performance of the right atrium
Time frame: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Echocardiographic parameter to analyze the vena cava inferior
Time frame: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Heart rate variability
Time frame: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Haemodynamic parameter of the bio-impedance monitoring
Time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Shock indices of the bio-impedance monitoring
Time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Heart sounds
Time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Tonometric arterial blood pressure
Time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Haemodynamic parameter of the tonometric pulse-contour method
Time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Mean systemic filling pressure
Time frame: At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40)
Questionnaire regarding alimentation
Time frame: Immediately prior to the start of the study protocol
Bio-impedance analysis of the body fluid
Time frame: Immediately prior to the start of the study protocol
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 2 Oct 2018.
- Derived from this study: PubMed 37265333Feldheiser A, Juhl-Olsen P, Nordine M, Stetzuhn M, Wiegank L, Knebel F, Treskatsch S, Berger C. A comprehensive echocardiographic analysis during simulated hypovolaemia: An observational study. Eur J Anaesthesiol. 2023 Aug 1;40(8):578-586. doi: 10.1097/EJA.0000000000001863. Epub 2023 Jun 1.
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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.
Aarne Feldheiser, MD, PhD principal investigator
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin Berlin, Germany, 13353 Berlin
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 Health, Subjective, run by Charite University, Berlin, Germany at 1 site in Germany.
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 13 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 2 Oct 2018. 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 Germany. 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?
Changes in the pulse-contour-analysis of the plethysmographic signal (time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)). The study lists 2 primary outcomes in all. 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 NCT03481855, 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 2 Oct 2018.