Clinical trial NCT03263988: HD Sense Pilot Study - A Novel Method of Hemodynamic Monitoring
Official title: A Novel Method of Hemodynamic Monitoring by Piezocapacitative Interlayer Sensor Technology - A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamic Instability
Keywords: pulse contour analysis
capton
intraoperative monitoring
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18 years or older voluntary patients undergoing elective surgery at Charité - Universitätsmedizin Berlin Campus Charite Mitte

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)

Eligibility criteria: 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

Primary outcomes:
measure: PPV
timeFrame: Duration of surgery and perioperative care (an average of 24 hours)
Secondary outcomes:
measure: Duration of surgery
timeFrame: Duration of surgery (an average of 4 hours)
measure: Duration of anesthesia
timeFrame: Duration of surgery (an average of 4 hours)
measure: intraoperative blood loss
timeFrame: Duration of surgery and perioperative care (an average of 24 hours)
measure: Duration of mechanical ventilation
timeFrame: Duration of surgery (an average of 4 hours)
measure: Duration of renal replacement therapy
timeFrame: perioperative (an average of 10 days)
measure: Length of hospital stay
timeFrame: perioperative (an average of 10 days)
measure: Blood products and volume needed perioperative
timeFrame: perioperative (an average of 10 days)
measure: ICU scores (TISS)
timeFrame: perioperative (an average of 10 days)
measure: ICU scores (SOFA)
timeFrame: perioperative (an average of 10 days)
measure: ICU scores (SAPS)
timeFrame: perioperative (an average of 10 days)
measure: Incidence of organ failure or complications
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/blood pressure
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/heart frequency
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/Cardiac index
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/stroke volume
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/pulse pressure variation
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/systemic vascular resistance index
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/intrathoracic blood volume index
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/extra vascular lung water index
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/global enddiastolic volume index
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/Ventilator settings
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/blood gases
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/creatinine
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/central venous oxygen saturation
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/central venous pressure
timeFrame: perioperative (an average of 10 days)
measure: Vital signs of patients/diuresis
timeFrame: perioperative (an average of 10 days)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin Campus Charité Mitte
Study officials:
affiliation: Charite University, Berlin, Germany
name: Sascha Treskatsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
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