Cardiac Output, Cardiac Surgery, Hemodynamic Monitoring
Conditions
Keywords
hemodynamic monitoring, cardiac output, cardiac surgery
Brief summary
Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or cardiac output due to hypovolemia or cardiac defects play a central role in causing poor peripheral tissue oxygenation. In order to assess stroke volume, there are numerous invasive and non-invasive methods available. Up to the present date it is unknown, if these methods may by used interchangeably in patients with severe cardiac defects like aortic stenosis.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* scheduled transcatheter aortic valve implantation * signed patient consent form * aged 18 or older by time of surgery * no participation in other clinical trials
Exclusion criteria
* pregnant or breast-feeding women * emergency surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of stroke volume (ml) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter | Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Measurement of cardiac output (l/min) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter | Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of cardiac output (l/min) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter | After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Accordance of stroke volume and cardiac output measurements assessed by (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter AFTER ADMINISTRATION OF FLUID BOLUS | Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Accordance of stroke volume and cardiac output measurements assessed by two of the mentioned methods [i.e. (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter] | Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Measurement of stroke volume (ml) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter | After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
Other
| Measure | Time frame |
|---|---|
| dosage of inotropic medication (mg/d) | after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| length of hospital stay | after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| incidence of stroke | after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| oxygen delivery (ml) | Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| image quality of echocardiography | Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Length of stay on ICU | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Cumulative rate of infections | after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| incidence of delirium after surgery | after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
Countries
Germany
Contacts
Primary ContactMichael Sander, MD
Outcome results
None listed