HD Sense Pilot Study - a Novel Method of Hemodynamic Monitoring

February 13, 2025 updated by: Sascha Treskatsch, Charite University, Berlin, Germany

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • Charité - Universitätsmedizin Berlin Campus Charité Mitte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

18 years or older voluntary patients undergoing elective surgery at Charité - Universitätsmedizin Berlin Campus Charite Mitte

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • pAVK Fontaine IV
  • arrythmia absoluta
  • vitium cordis >/=3
  • ejection fraction <35%
  • TAPSE </=16mm
  • need of IABP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PIEZO-Group
All patients in this study receive IBP by PICCO and piezocapacitative-interlayer-technology measurement.
Device: ConCardiac
All patients receive a piezocapacitative-interlayer-technology hemodynamic measurement by ConCardiac device (SectorCon GmbH, Berlin, Germany).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Duration of surgery and perioperative care (an average of 24 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of surgery
Time Frame: Duration of surgery (an average of 4 hours)
Duration of surgery (an average of 4 hours)
Duration of anesthesia
Time Frame: Duration of surgery (an average of 4 hours)
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 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 surgery (an average of 4 hours)
Duration of renal replacement therapy
Time Frame: perioperative (an average of 10 days)
perioperative (an average of 10 days)
Length of hospital stay
Time Frame: perioperative (an average of 10 days)
perioperative (an average of 10 days)
Blood products and volume needed perioperative
Time Frame: perioperative (an average of 10 days)
perioperative (an average of 10 days)
ICU scores (TISS)
Time Frame: perioperative (an average of 10 days)
perioperative (an average of 10 days)
ICU scores (SOFA)
Time Frame: perioperative (an average of 10 days)
perioperative (an average of 10 days)
ICU scores (SAPS)
Time Frame: perioperative (an average of 10 days)
perioperative (an average of 10 days)
Incidence of organ failure or complications
Time Frame: perioperative (an average of 10 days)
perioperative (an average of 10 days)
Vital signs of patients/blood pressure
Time Frame: perioperative (an average of 10 days)
RR
perioperative (an average of 10 days)
Vital signs of patients/heart frequency
Time Frame: perioperative (an average of 10 days)
HF
perioperative (an average of 10 days)
Vital signs of patients/Cardiac index
Time Frame: perioperative (an average of 10 days)
CI
perioperative (an average of 10 days)
Vital signs of patients/stroke volume
Time Frame: perioperative (an average of 10 days)
SV
perioperative (an average of 10 days)
Vital signs of patients/pulse pressure variation
Time Frame: perioperative (an average of 10 days)
PPV
perioperative (an average of 10 days)
Vital signs of patients/systemic vascular resistance index
Time Frame: perioperative (an average of 10 days)
SVRI
perioperative (an average of 10 days)
Vital signs of patients/intrathoracic blood volume index
Time Frame: perioperative (an average of 10 days)
ITBV/I
perioperative (an average of 10 days)
Vital signs of patients/extra vascular lung water index
Time Frame: perioperative (an average of 10 days)
ELWI
perioperative (an average of 10 days)
Vital signs of patients/global enddiastolic volume index
Time Frame: perioperative (an average of 10 days)
GEDI
perioperative (an average of 10 days)
Vital signs of patients/Ventilator settings
Time Frame: perioperative (an average of 10 days)
Ventilator settings
perioperative (an average of 10 days)
Vital signs of patients/blood gases
Time Frame: perioperative (an average of 10 days)
BGA
perioperative (an average of 10 days)
Vital signs of patients/creatinine
Time Frame: perioperative (an average of 10 days)
Creatinine
perioperative (an average of 10 days)
Vital signs of patients/central venous oxygen saturation
Time Frame: perioperative (an average of 10 days)
ScvO2
perioperative (an average of 10 days)
Vital signs of patients/central venous pressure
Time Frame: perioperative (an average of 10 days)
CVP
perioperative (an average of 10 days)
Vital signs of patients/diuresis
Time Frame: perioperative (an average of 10 days)
Diuresis
perioperative (an average of 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sascha Treskatsch, MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HD Sense

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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