HD Sense Pilot Study - a Novel Method of Hemodynamic Monitoring

Charité University Medicine Berlin

Status: Completed

Conditions: Hemodynamic Instability

Treatments: Device: ConCardiac

Study type: Observational

Funder types: Other

Identifiers

NCT03263988

HD Sense

Details and patient eligibility

About

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.

Full 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)

Enrollment: 39 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

39 participants in 1 patient group

PIEZO-Group

Description:

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

Treatment:

Device: ConCardiac