HD Sense Pilot Study - a Novel Method of Hemodynamic Monitoring

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: Completed
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Device: ConCardiac

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: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
PPV	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

Outcome Measure	Measure Description	Time Frame
Duration of surgery		Duration of surgery (an average of 4 hours)
Duration of anesthesia		Duration of surgery (an average of 4 hours)
intraoperative blood loss		Duration of surgery and perioperative care (an average of 24 hours)
Duration of mechanical ventilation		Duration of surgery (an average of 4 hours)
Duration of renal replacement therapy		perioperative (an average of 10 days)
Length of hospital stay		perioperative (an average of 10 days)
Blood products and volume needed perioperative		perioperative (an average of 10 days)
ICU scores (TISS)		perioperative (an average of 10 days)
ICU scores (SOFA)		perioperative (an average of 10 days)
ICU scores (SAPS)		perioperative (an average of 10 days)
Incidence of organ failure or complications		perioperative (an average of 10 days)
Vital signs of patients/blood pressure	RR	perioperative (an average of 10 days)
Vital signs of patients/heart frequency	HF	perioperative (an average of 10 days)
Vital signs of patients/Cardiac index	CI	perioperative (an average of 10 days)
Vital signs of patients/stroke volume	SV	perioperative (an average of 10 days)
Vital signs of patients/pulse pressure variation	PPV	perioperative (an average of 10 days)
Vital signs of patients/systemic vascular resistance index	SVRI	perioperative (an average of 10 days)
Vital signs of patients/intrathoracic blood volume index	ITBV/I	perioperative (an average of 10 days)
Vital signs of patients/extra vascular lung water index	ELWI	perioperative (an average of 10 days)
Vital signs of patients/global enddiastolic volume index	GEDI	perioperative (an average of 10 days)
Vital signs of patients/Ventilator settings	Ventilator settings	perioperative (an average of 10 days)
Vital signs of patients/blood gases	BGA	perioperative (an average of 10 days)
Vital signs of patients/creatinine	Creatinine	perioperative (an average of 10 days)
Vital signs of patients/central venous oxygen saturation	ScvO2	perioperative (an average of 10 days)
Vital signs of patients/central venous pressure	CVP	perioperative (an average of 10 days)
Vital signs of patients/diuresis	Diuresis	perioperative (an average of 10 days)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Sascha Treskatsch, MD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Auler 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.
• Scheer 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.
• 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.
• Scheeren 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.
• Dalfino 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.
• Sun 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2017
• Primary Completion (Actual): October 23, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: intraoperative monitoring; pulse contour analysis; capton
• Other Study ID 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