HD Sense Pilot Study - a Novel Method of Hemodynamic Monitoring

Completed

• Conditions: Hemodynamic Instability
• Interventions: Device: ConCardiac

• Registration Number: NCT03263988
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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. 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 Timeline

• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-28
• Study Start: 2017-10-19
• Primary Completion: 2018-10-23
• Study Completion: 2019-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PIEZO-Group	ConCardiac	All patients in this study receive IBP by PICCO and piezocapacitative-interlayer-technology measurement.

Primary Outcome Measures

Name	Time	Method
PPV	Duration of surgery and perioperative care (an average of 24 hours)	Percentual error of PPV \< 30% for ConCardiac between ConCardiac and PICCO

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin Campus Charité Mitte; 🇩🇪 Berlin, Germany