Stroke Volume Analysis During Aortic Valve Replacement Trial

Charite University, Berlin, Germany68 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hemodynamic Monitoring Cardiac Output Cardiac Surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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]

Time frame: Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

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

Time frame: After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks