Hemodynamic InstabilityNCT03263988
HD Sense Pilot Study - A Novel Method of Hemodynamic Monitoring
An observational study of Hemodynamic Instability, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic parameter of hemodynamic optimization. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- ConCardiac
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- 19 Oct 2017to 31 Dec 2019
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 years or older voluntary patients undergoing elective surgery at Charité - Universitätsmedizin Berlin Campus Charite Mitte
Who may be able to join
- elective surgery and general anesthesia
- age >/= 18 years
- any surgery in ENT/trauma/gynecology/visceral surgery/thoracic surgery/urology/neuro surgery/cardio surgery (N=10)
- cardio surgery (N=10)
- Transcatheter Aortic Valve Implantation (N=20)
- cystectomy (N=10)
- neurosurgery with an expected postoperative ICU stay >/= 20 hours (N=10)
Who cannot join
- pregnant or breastfeeding patients
- emergency surgery
- participation in a clinical interventional study
- BMI >35 kg/m²
- impossibility to place the ConCardiac interlayer
- difference of blood pressure of right and left arm > 12 mmHg
Show all 12Show fewer
- pAVK Fontaine IV
- arrythmia absoluta
- vitium cordis >/=3
- ejection fraction <35%
- TAPSE </=16mm
- need of IABP
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin Campus Charité Mitte
Berlin, State of Berlin, 10115
About this study
Official title: A Novel Method of Hemodynamic Monitoring by Piezocapacitative Interlayer Sensor Technology - A Pilot Study
Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic parameter of hemodynamic optimization. Until now standard methods for blood pressure measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct, continuous and invasive by inserting an intraarterial catheter. This observational study will show, that a new non-invasive piezocapacitative-interlayer technology will make continuous blood pressure monitoring and non-invasive pulse contour analysis available.
Read the detailed description
Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic parameter of hemodynamic optimization. Until now standard methods for blood pressure measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct, continuous and invasive by inserting an intraarterial catheter. This observational study will show, that a new non-invasive piezocapacitative-interlayer technology will make continuous blood pressure monitoring and non-invasive pulse contour analysis available. For this reason all patients will get a basic monitoring (NIBP, ECG, SpO2)
- Conditions
- Hemodynamic Instability
- Being tested
- ConCardiac
- Keywords
- pulse contour analysis, capton, intraoperative monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConCardiacDevice
All patients receive a piezocapacitative-interlayer-technology hemodynamic measurement by ConCardiac device (SectorCon GmbH, Berlin, Germany).
| Study group | Role | What they receive |
|---|---|---|
| PIEZO-Group | All patients in this study receive IBP by PICCO and piezocapacitative-interlayer-technology measurement. Receives: Device: ConCardiac |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPV
Percentual error of PPV < 30% for ConCardiac between ConCardiac and PICCO
Measured: Duration of surgery and perioperative care (an average of 24 hours)
Secondary outcomes (26)
Duration of surgery
Measured: Duration of surgery (an average of 4 hours)
Duration of anesthesia
Measured: Duration of surgery (an average of 4 hours)
intraoperative blood loss
Measured: Duration of surgery and perioperative care (an average of 24 hours)
Duration of mechanical ventilation
Measured: Duration of surgery (an average of 4 hours)
Duration of renal replacement therapy
Measured: perioperative (an average of 10 days)
Length of hospital stay
Measured: perioperative (an average of 10 days)
Blood products and volume needed perioperative
Measured: perioperative (an average of 10 days)
ICU scores (TISS)
Measured: perioperative (an average of 10 days)
ICU scores (SOFA)
Measured: perioperative (an average of 10 days)
ICU scores (SAPS)
Measured: perioperative (an average of 10 days)
Incidence of organ failure or complications
Measured: perioperative (an average of 10 days)
Vital signs of patients/blood pressure
RR
Measured: perioperative (an average of 10 days)
Vital signs of patients/heart frequency
HF
Measured: perioperative (an average of 10 days)
Vital signs of patients/Cardiac index
CI
Measured: perioperative (an average of 10 days)
Vital signs of patients/stroke volume
SV
Measured: perioperative (an average of 10 days)
Vital signs of patients/pulse pressure variation
PPV
Measured: perioperative (an average of 10 days)
Vital signs of patients/systemic vascular resistance index
SVRI
Measured: perioperative (an average of 10 days)
Vital signs of patients/intrathoracic blood volume index
ITBV/I
Measured: perioperative (an average of 10 days)
Vital signs of patients/extra vascular lung water index
ELWI
Measured: perioperative (an average of 10 days)
Vital signs of patients/global enddiastolic volume index
GEDI
Measured: perioperative (an average of 10 days)
Vital signs of patients/Ventilator settings
Ventilator settings
Measured: perioperative (an average of 10 days)
Vital signs of patients/blood gases
BGA
Measured: perioperative (an average of 10 days)
Vital signs of patients/creatinine
Creatinine
Measured: perioperative (an average of 10 days)
Vital signs of patients/central venous oxygen saturation
ScvO2
Measured: perioperative (an average of 10 days)
Vital signs of patients/central venous pressure
CVP
Measured: perioperative (an average of 10 days)
Vital signs of patients/diuresis
Diuresis
Measured: perioperative (an average of 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start19 Oct 2017
- Primary completion23 Oct 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sascha Treskatsch, Charite University, Berlin, Germany
- Investigators
- Sascha Treskatsch, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263988
- Sponsor's protocol ID
- HD Sense
- Status last verified
- Feb 2025
- First submitted
- 21 Aug 2017
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
PubMed 19837807Scheer B, Perel A, Pfeiffer UJ. Clinical review: complications and risk factors of peripheral arterial catheters used for haemodynamic monitoring in anaesthesia and intensive care medicine. Crit Care. 2002 Jun;6(3):199-204. doi: 10.1186/cc1489. Epub 2002 Apr 18.
PubMed 12133178Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. Epub 2013 Apr 5.
PubMed 23558909Auler JO Jr, Galas F, Hajjar L, Santos L, Carvalho T, Michard F. Online monitoring of pulse pressure variation to guide fluid therapy after cardiac surgery. Anesth Analg. 2008 Apr;106(4):1201-6, table of contents. doi: 10.1213/01.ane.0000287664.03547.c6.
PubMed 18349193Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care. 2011 Jun 24;15(3):R154. doi: 10.1186/cc10284.
PubMed 21702945Sun Y, Lacour SP, Brooks RA, Rushton N, Fawcett J, Cameron RE. Assessment of the biocompatibility of photosensitive polyimide for implantable medical device use. J Biomed Mater Res A. 2009 Sep 1;90(3):648-55. doi: 10.1002/jbm.a.32125.
PubMed 18563817
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Method of Hemodynamic Monitoring by Piezocapacitative Interlayer Sensor Technology - A Pilot Study
- ClinicalTrials.gov ID
- NCT03263988
- Acronym / sponsor ID
- HD Sense
- Conditions
- Hemodynamic Instability
- Keywords
- pulse contour analysis, capton, intraoperative monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Aug 2017 (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.
Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic parameter of hemodynamic optimization. Until now standard methods for blood pressure measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct, continuous and invasive by inserting an intraarterial catheter. This observational study will show, that a new non-invasive piezocapacitative-interlayer technology will make continuous blood pressure monitoring and non-invasive pulse contour analysis available.
Detailed description
Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic parameter of hemodynamic optimization. Until now standard methods for blood pressure measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct, continuous and invasive by inserting an intraarterial catheter. This observational study will show, that a new non-invasive piezocapacitative-interlayer technology will make continuous blood pressure monitoring and non-invasive pulse contour analysis available. For this reason all patients will get a basic monitoring (NIBP, ECG, SpO2)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PIEZO-Group | – | Device: ConCardiacAll patients in this study receive IBP by PICCO and piezocapacitative-interlayer-technology measurement. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years or older voluntary patients undergoing elective surgery at Charité - Universitätsmedizin Berlin Campus Charite Mitte
Key inclusion criteria (7 listed)
- elective surgery and general anesthesia
- age >/= 18 years
- any surgery in ENT/trauma/gynecology/visceral surgery/thoracic surgery/urology/neuro surgery/cardio surgery (N=10)
- cardio surgery (N=10)
- Transcatheter Aortic Valve Implantation (N=20)
Key exclusion criteria (12 listed)
- pregnant or breastfeeding patients
- emergency surgery
- participation in a clinical interventional study
- BMI >35 kg/m²
- impossibility to place the ConCardiac interlayer
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 |
|---|---|---|
| ConCardiacAll patients receive a piezocapacitative-interlayer-technology hemodynamic measurement by ConCardiac device (SectorCon GmbH, Berlin, Germany). | Device | PIEZO-Group |
Primary outcome
PPV
Time frame: Duration of surgery and perioperative care (an average of 24 hours)
Percentual error of PPV < 30% for ConCardiac between ConCardiac and PICCO
26 secondary outcomes
Duration of surgery
Time frame: Duration of surgery (an average of 4 hours)
Duration of anesthesia
Time frame: Duration of surgery (an average of 4 hours)
intraoperative blood loss
Time frame: Duration of surgery and perioperative care (an average of 24 hours)
Duration of mechanical ventilation
Time frame: Duration of surgery (an average of 4 hours)
Duration of renal replacement therapy
Time frame: perioperative (an average of 10 days)
Length of hospital stay
Time frame: perioperative (an average of 10 days)
Blood products and volume needed perioperative
Time frame: perioperative (an average of 10 days)
ICU scores (TISS)
Time frame: perioperative (an average of 10 days)
ICU scores (SOFA)
Time frame: perioperative (an average of 10 days)
ICU scores (SAPS)
Time frame: perioperative (an average of 10 days)
Incidence of organ failure or complications
Time frame: perioperative (an average of 10 days)
Vital signs of patients/blood pressure
Time frame: perioperative (an average of 10 days)
Vital signs of patients/heart frequency
Time frame: perioperative (an average of 10 days)
Vital signs of patients/Cardiac index
Time frame: perioperative (an average of 10 days)
Vital signs of patients/stroke volume
Time frame: perioperative (an average of 10 days)
Vital signs of patients/pulse pressure variation
Time frame: perioperative (an average of 10 days)
Vital signs of patients/systemic vascular resistance index
Time frame: perioperative (an average of 10 days)
Vital signs of patients/intrathoracic blood volume index
Time frame: perioperative (an average of 10 days)
Vital signs of patients/extra vascular lung water index
Time frame: perioperative (an average of 10 days)
Vital signs of patients/global enddiastolic volume index
Time frame: perioperative (an average of 10 days)
Vital signs of patients/Ventilator settings
Time frame: perioperative (an average of 10 days)
Vital signs of patients/blood gases
Time frame: perioperative (an average of 10 days)
Vital signs of patients/creatinine
Time frame: perioperative (an average of 10 days)
Vital signs of patients/central venous oxygen saturation
Time frame: perioperative (an average of 10 days)
Vital signs of patients/central venous pressure
Time frame: perioperative (an average of 10 days)
Vital signs of patients/diuresis
Time frame: perioperative (an average of 10 days)
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 14 Feb 2025.
- Background: PubMed 19837807Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
- Background: PubMed 12133178Scheer B, Perel A, Pfeiffer UJ. Clinical review: complications and risk factors of peripheral arterial catheters used for haemodynamic monitoring in anaesthesia and intensive care medicine. Crit Care. 2002 Jun;6(3):199-204. doi: 10.1186/cc1489. Epub 2002 Apr 18.
- Background: PubMed 23558909Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. Epub 2013 Apr 5.
- Background: PubMed 18349193Auler JO Jr, Galas F, Hajjar L, Santos L, Carvalho T, Michard F. Online monitoring of pulse pressure variation to guide fluid therapy after cardiac surgery. Anesth Analg. 2008 Apr;106(4):1201-6, table of contents. doi: 10.1213/01.ane.0000287664.03547.c6.
- Background: PubMed 21702945Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care. 2011 Jun 24;15(3):R154. doi: 10.1186/cc10284.
- Background: PubMed 18563817Sun Y, Lacour SP, Brooks RA, Rushton N, Fawcett J, Cameron RE. Assessment of the biocompatibility of photosensitive polyimide for implantable medical device use. J Biomed Mater Res A. 2009 Sep 1;90(3):648-55. doi: 10.1002/jbm.a.32125.
- Individual participant dataSharing planned: No
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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.
Sascha Treskatsch, MD principal investigator
Charite University, Berlin, Germany
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 Hemodynamic Instability, 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 7 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 14 Feb 2025. 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?
PPV (time frame: Duration of surgery and perioperative care (an average of 24 hours)). 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 NCT03263988, which also lists 6 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 14 Feb 2025.