I50.9 I25.0 Z95.1 Z95.2 Z95.3 R57.2 R57.0
Conditions
Interventions
Group 1: The aim of the proposed study is to evaluate whether the RATPA device can serve as an efficient, non-invasive alternative to the use of a pulmonary artery catheter (PAC) in patients after hea
Sponsors
RWTH Uniklinik Aachen, Klinik für Herzchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Legal age 2. HFrEF (Heart Failure with Reduced Ejection Fraction < 40%) 3. Patients diagnosed with ischemic heart disease and planned elective or emergency aorto-coronary bypass (ACB) surgery 4. Patients with a diagnosis of valvular heart disease and planned elective or emergency valve replacement surgery 5. Patients with septic shock
Exclusion criteria
Exclusion criteria: 1. Pregnant women 2. Patients with aortic valve defect who have received a mechanical aortic valve replacement or are planned for replacement 3. Patients with congenital heart disease 4. Lack of consent and/or lack of capacity to consent of the patient 5. The RATPA should not be used in patients with the following conditions: 6. a) Patients with severe arrhythmia 7. b) Patients with severe peripheral arterial occlusive disease (PAOD) 8. c) Patients in whom the artery cannot be found by palpation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study Procedure: The RATPA examination is conducted at nine time points, namely preoperatively after elective admission to the general ward, on the day of surgery in the operating room, and during the application of the pulmonary artery catheter (PAC). The values of the RATPA and the PAC must be recorded simultaneously and documented in an animated table, with both measurements being taken at the same time under standardized conditions (patient lying flat, arm at heart level). All relevant data, such as measurement time, patient position, and recorded values, must be continuously and consistently entered into the table. RATPA measurements are repeated simultaneously with the PAC data at various times: preoperatively in the operating room and postoperatively in the intensive care unit at the times of 0 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours. Simultaneously obtained transthoracic echocardiographic data serve to verify the PAC and RATPA measurements. The PAC and RATPA data are compared in terms of the accuracy and precision of the measurements, including stroke volume (SV), cardiac output (CO), pulse, peripheral resistance, and blood pressure (BP). Through the simultaneously collected data from patients in the intensive care unit, valuable insights can be gained regarding the applicability of RATPA in pharmacologically altered hemodynamics, particularly during treatment with vasodilators or vasopressors. Furthermore, the proposed study aims to assess the feasibility, safety, and accessibility of RATPA in patients in the critical phase immediately after heart surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of the degree of change in the flow profile and comparison of the findings with the hemodynamic parameters of the PAC under echocardiographic control. | — |
Countries
Germany
Contacts
Public ContactAhmed Farghal Ahmed Mohammed
RWTH Uniklinik Aachen, Klinik für Herzchirurgie
Outcome results
None listed