HD Sense Pilot Study - A Novel Method of Hemodynamic Monitoring

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03263988
• Other study ID #: HD Sense
• Status: Active, not recruiting
• Start date: October 19, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: December 31, 2019
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

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

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin Campus Charité Mitte	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Auler JO Jr, Galas F, Hajjar L, Santos L, Carvalho T, Michard F. Online monitoring of pulse pressure variation to guide fluid therapy after cardiac surgery. Anesth Analg. 2008 Apr;106(4):1201-6, table of contents. doi: 10.1213/01.ane.0000287664.03547.c6. — View Citation

Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care. 2011 Jun 24;15(3):R154. doi: 10.1186/cc10284. Review. — View Citation

Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279. Review. — View Citation

Scheer B, Perel A, Pfeiffer UJ. Clinical review: complications and risk factors of peripheral arterial catheters used for haemodynamic monitoring in anaesthesia and intensive care medicine. Crit Care. 2002 Jun;6(3):199-204. Epub 2002 Apr 18. Review. — View Citation

Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. Epub 2013 Apr 5. — View Citation

Sun Y, Lacour SP, Brooks RA, Rushton N, Fawcett J, Cameron RE. Assessment of the biocompatibility of photosensitive polyimide for implantable medical device use. J Biomed Mater Res A. 2009 Sep 1;90(3):648-55. doi: 10.1002/jbm.a.32125. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PPV	Percentual error of PPV < 30% for ConCardiac between ConCardiac and PICCO	Duration of surgery and perioperative care (an average of 24 hours)
Secondary	Duration of surgery		Duration of surgery (an average of 4 hours)
Secondary	Duration of anesthesia		Duration of surgery (an average of 4 hours)
Secondary	intraoperative blood loss		Duration of surgery and perioperative care (an average of 24 hours)
Secondary	Duration of mechanical ventilation		Duration of surgery (an average of 4 hours)
Secondary	Duration of renal replacement therapy		perioperative (an average of 10 days)
Secondary	Length of hospital stay		perioperative (an average of 10 days)
Secondary	Blood products and volume needed perioperative		perioperative (an average of 10 days)
Secondary	ICU scores (TISS)		perioperative (an average of 10 days)
Secondary	ICU scores (SOFA)		perioperative (an average of 10 days)
Secondary	ICU scores (SAPS)		perioperative (an average of 10 days)
Secondary	Incidence of organ failure or complications		perioperative (an average of 10 days)
Secondary	Vital signs of patients/blood pressure	RR	perioperative (an average of 10 days)
Secondary	Vital signs of patients/heart frequency	HF	perioperative (an average of 10 days)
Secondary	Vital signs of patients/Cardiac index	CI	perioperative (an average of 10 days)
Secondary	Vital signs of patients/stroke volume	SV	perioperative (an average of 10 days)
Secondary	Vital signs of patients/pulse pressure variation	PPV	perioperative (an average of 10 days)
Secondary	Vital signs of patients/systemic vascular resistance index	SVRI	perioperative (an average of 10 days)
Secondary	Vital signs of patients/intrathoracic blood volume index	ITBV/I	perioperative (an average of 10 days)
Secondary	Vital signs of patients/extra vascular lung water index	ELWI	perioperative (an average of 10 days)
Secondary	Vital signs of patients/global enddiastolic volume index	GEDI	perioperative (an average of 10 days)
Secondary	Vital signs of patients/Ventilator settings	Ventilator settings	perioperative (an average of 10 days)
Secondary	Vital signs of patients/blood gases	BGA	perioperative (an average of 10 days)
Secondary	Vital signs of patients/creatinine	Creatinine	perioperative (an average of 10 days)
Secondary	Vital signs of patients/central venous oxygen saturation	ScvO2	perioperative (an average of 10 days)
Secondary	Vital signs of patients/central venous pressure	CVP	perioperative (an average of 10 days)
Secondary	Vital signs of patients/diuresis	Diuresis	perioperative (an average of 10 days)