Right Ventricular Function and Venous Return
Conditions
Brief summary
In this prospective, observational study the investigators assess the perioperative course of right ventricular function in combination with the venous return in patients undergoing major non-cardiac surgery. The study aims to investigate if patients undergoing major non-cardiac surgery develop an impairment of right ventricular function and/or venous return. Furthermore, the study evaluates if an impairment of right ventricular function and/or venous return is associated to left ventricular function, arterial side of the circulation and to postoperative clinical outcome.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Offered patient information and written informed consent * Female patients aged greater than or equal to 18 years for cytoreductive surgery of a primary epithelial ovarian tumour 1. Patient Group 1: Female patients with \> 500 ml ascites in the preoperative sonographic examination 2. Patient group 2: Female patients aged \> 70 years and at least one of the following secondary diagnoses: * Status Post stent placement due to coronary heart disease respectively Status Post-myocardial infarction * existing arterial Hypertension for more than 5 years * chronic heart failure (New York Heart Association (NYHA) class II-III) * peripheral arterial disease
Exclusion criteria
* Patients aged less than 18 years * Persons without the capacity to consent * Inability of German language use * Lacking willingness to save and hand out data within the study * Accommodation in an institution due to an official or judicial order * (Unclear) history of alcohol or substances disabuse * Coworker of the Charité * Advanced disease of the oesophagus or upper respiratory tract at the beginning of hospitalization * Operation in the area of the oesophagus or nasopharynx within the last two months before participation in the study * Neurological or psychiatric disease at the beginning of hospitalization * CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospitalization * American Society of Anesthesiologists (ASA) classification greater than IV * Renal insufficiency (dependency of haemodialysis) at the beginning of hospitalization * Pulmonary oedema in thorax x-ray at the beginning of hospitalization * History of intracranial hemorrhage within one year before participation in the study * Conditions following venous thrombosis within the last three years before study inclusion * Known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions * Diabetes mellitus with signs of severe neuropathy * Known atrial fibrillation * Participation in an interventional clinical trial during the study period; exception: assignment to adjuvant therapy study during this study is allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Venous return | Up to the first postoperative day | Venous return will be assessed perioperatively by venous return pressure gradient (dVR) |
| Right ventricular function | Up to the first postoperative day | Right ventricular function will be measured perioperatively by a combination of right ventricular stroke volume, tricuspid annular plane systolic excursion (TAPSE), hepatic venous blood flow, variations in diameter of vena cavae, and right ventricle/left ventricle-ratio. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variables of transthoracic and transesophageal echocardiography | Up to the first postoperative day | Perioperative course of variables of transthoracic and transesophageal echocardiography |
| Venous return variables according to Guyton concept | Up to the first postoperative day | Perioperative course of variables according to Guyton concept characterizing venous return |
| Hemodynamic variables | Up to the third postoperative day | Hemodynamic variables are assessed by the anesthesia monitor and esophageal Doppler Monitor |
| Catecholamine administration | Up to the third postoperative day | Catecholamine administration intra- und postoperative |
| Immunological parameter | Up to the third postoperative day | Perioperative immunological (IL-6 und TNF-alpha) |
| Endothelial parameter | Up to the third postoperative day | Perioperative endothelial Parameter (ICAM-1) |
| Microvascular function | Up to the first postoperative day | Perioperative course of variables assessing microvascular function |
| Fluid balance | Up to the third postoperative day | Fluid and volume administration and balance intra- und postoperative |
| Organ complications | Participants will be followed up until hospital discharge, an average of two weeks | Postoperative organ complications are classified according to Clavien - Dindo classification |
| Postoperative pain | Up to the third postoperative day | Postoperative pain will be measured by Numeric Rating Scale - Visualized (NRS-V), the Faces Pain Scale - Revised (FPS-R), the Behavioral Pain Scale (BPS) or the Behavioral Pain Scale for Non-Intubated (BPS-NI) |
| Hospital length of stay | Participants will be followed up until hospital discharge, an average of two weeks | — |
| Quality of life | Baseline and hospital discharge with an expected average of 14 days | Assessed with EQ-5D questionnaire |
| Functional status | Baseline and hospital discharge with an expected average stay of 14 days | Measured by the Barthel activities of daily living (ADL) index and activities of daily living (IADL). |
| Blood loss | Up to the third postoperative day | Blood loss characteristics intra- und postoperative |
| Intensive care unit length of stay | Participants will be followed up until intensive crae unit discharge, an average of two days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of right ventricular function index | Up to the first postoperative day | Right ventricular function index will be evaluated by a combination of right ventricular stroke volume, tricuspid annular plane systolic excursion (TAPSE), hepatic venous blood flow, variations in diameter of vena cavae and right ventricle/left ventricle-ratio. |
Countries
Germany
Outcome results
None listed