HD Sense Pilot Study - A Novel Method of Hemodynamic Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-19

Study Completion Date

2019-12-31

Brief Summary

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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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Detailed Description

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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

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Hemodynamic Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PIEZO-Group

All patients in this study receive IBP by PICCO and piezocapacitative-interlayer-technology measurement.

ConCardiac

Intervention Type DEVICE

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

Interventions

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ConCardiac

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No