Patients admitted at a cardio thorasic Intensive care for hemodynamic monitoring Patients admitted for hemodynamic monitoring
Conditions
Interventions
A Draeger Infinity M540 patient monitor with modified hardware for ECG data processing
Sponsors
Drägerwerk AG & Co. KGaA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients admitted in the intensive care Patients 18 years and above for whom cardiac and/or hemodynamic monitoring is indicated. Subjects hospitalized for any reason, with or without having undergone surgery, and monitored by IACS as standard of care in the study site. Patients presenting with a permanent pacemaker implanted IEC approved, written informed consent obtained from the subject and/or the subject’s legal representative prior to starting the study data recording period and transferring any data from the Infinity Acute Care System to the sponsor.
Exclusion criteria
Exclusion criteria: Patients below 18 years of age (pediatrics, neonates) Patient in hyperbaric chamber Patient in environment containing MRI equipment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to determine if it is adequate to discern noise issues and environmental effects when the investigational device is used in a hospital setting. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint for data collected from participants with pacemakers enrolled in the second group, the type of pacemaker and settings will be observed and the position of pace pulses annotated relative to QRS complex (paced rhythm representing ventricular depolarization). Collected study data will be processed through an analysis software that pulls apart ECG channels and Pace channels, then data will be compared to current performance standards in commercially cleared, CE marked version of the M540 patient monitor. | — |
Countries
Netherlands
Contacts
Public ContactAV Valentin
Draeger Medical Systems, Inc.
Outcome results
None listed