HD Sense Pilot Study - A Novel Method of Hemodynamic Monitoring

NCT03263988 | Completed

• 1 other identifier: HD Sense
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability

Keywords

pulse contour analysis; capton; intraoperative monitoring

Outcome Measures

Primary Outcomes (1)

• PPV

  Percentual error of PPV \< 30% for ConCardiac between ConCardiac and PICCO

  Duration of surgery and perioperative care (an average of 24 hours)

Secondary Outcomes (26)

• Duration of surgery

  Duration of surgery (an average of 4 hours)

• Duration of anesthesia

  Duration of surgery (an average of 4 hours)

• intraoperative blood loss

  Duration of surgery and perioperative care (an average of 24 hours)

• Duration of mechanical ventilation

  Duration of surgery (an average of 4 hours)

• Duration of renal replacement therapy

  perioperative (an average of 10 days)

Study Arms (1)

PIEZO-Group

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

Device: ConCardiac

Interventions

ConCardiac DEVICE

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

PIEZO-Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

18 years or older voluntary patients undergoing elective surgery at Charité - Universitätsmedizin Berlin Campus Charite Mitte

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin Campus Charité Mitte

Berlin, State of Berlin, 10115, Germany

Location

Related Publications (6)

• 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.

  PMID: 19837807 BACKGROUND

• 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. doi: 10.1186/cc1489. Epub 2002 Apr 18.

  PMID: 12133178 BACKGROUND

• 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.

  PMID: 23558909 BACKGROUND

• 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.

  PMID: 18349193 BACKGROUND

• 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.

  PMID: 21702945 BACKGROUND

• 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.

  PMID: 18563817 BACKGROUND

Study Officials

• Sascha Treskatsch, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med./ Deputy head of department

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 28, 2017
• Study Start: October 19, 2017
• Primary Completion: October 23, 2018
• Study Completion: December 31, 2019
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)