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NCT Number: NCT03263988

HD Sense Pilot Study - A Novel Method of Hemodynamic Monitoring

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.

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Key information

Conditions

Hemodynamic Instability

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin Berlin Campus Charité Mitte

Berlin, State of Berlin, 10115, Germany

About this 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. For this reason all patients will get a basic monitoring (NIBP, ECG, SpO2)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ConCardiac

Device

All patients receive a piezocapacitative-interlayer-technology hemodynamic measurement by ConCardiac device (SectorCon GmbH, Berlin, Germany).

Primary outcomes

  1. 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

Secondary outcomes

  1. Duration of surgery

    Time frame: Duration of surgery (an average of 4 hours)

  2. Duration of anesthesia

    Time frame: Duration of surgery (an average of 4 hours)

  3. intraoperative blood loss

    Time frame: Duration of surgery and perioperative care (an average of 24 hours)

  4. Duration of mechanical ventilation

    Time frame: Duration of surgery (an average of 4 hours)

  5. Duration of renal replacement therapy

    Time frame: perioperative (an average of 10 days)

  6. Length of hospital stay

    Time frame: perioperative (an average of 10 days)

  7. Blood products and volume needed perioperative

    Time frame: perioperative (an average of 10 days)

  8. ICU scores (TISS)

    Time frame: perioperative (an average of 10 days)

  9. ICU scores (SOFA)

    Time frame: perioperative (an average of 10 days)

  10. ICU scores (SAPS)

    Time frame: perioperative (an average of 10 days)

  11. Incidence of organ failure or complications

    Time frame: perioperative (an average of 10 days)

  12. Vital signs of patients/blood pressure

    Time frame: perioperative (an average of 10 days)

    RR

  13. Vital signs of patients/heart frequency

    Time frame: perioperative (an average of 10 days)

    HF

  14. Vital signs of patients/Cardiac index

    Time frame: perioperative (an average of 10 days)

    CI

  15. Vital signs of patients/stroke volume

    Time frame: perioperative (an average of 10 days)

    SV

  16. Vital signs of patients/pulse pressure variation

    Time frame: perioperative (an average of 10 days)

    PPV

  17. Vital signs of patients/systemic vascular resistance index

    Time frame: perioperative (an average of 10 days)

    SVRI

  18. Vital signs of patients/intrathoracic blood volume index

    Time frame: perioperative (an average of 10 days)

    ITBV/I

  19. Vital signs of patients/extra vascular lung water index

    Time frame: perioperative (an average of 10 days)

    ELWI

  20. Vital signs of patients/global enddiastolic volume index

    Time frame: perioperative (an average of 10 days)

    GEDI

  21. Vital signs of patients/Ventilator settings

    Time frame: perioperative (an average of 10 days)

    Ventilator settings

  22. Vital signs of patients/blood gases

    Time frame: perioperative (an average of 10 days)

    BGA

  23. Vital signs of patients/creatinine

    Time frame: perioperative (an average of 10 days)

    Creatinine

  24. Vital signs of patients/central venous oxygen saturation

    Time frame: perioperative (an average of 10 days)

    ScvO2

  25. Vital signs of patients/central venous pressure

    Time frame: perioperative (an average of 10 days)

    CVP

  26. Vital signs of patients/diuresis

    Time frame: perioperative (an average of 10 days)

    Diuresis

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

A Novel Method of Hemodynamic Monitoring by Piezocapacitative Interlayer Sensor Technology - A Pilot Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 28, 2017
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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