Cardiopulmonary Diseases, Sepsis, Shock, ARDS
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Unplanned admission to the intensive care unit - Patient or caregiver is able to sign the consent - Signed informed consent
Exclusion criteria
Exclusion criteria: - Missing consent - Non-consentable patients for whom no caregiver is available - Echocardiogramm due to the same indication on the same day of admission to the intensive care unit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint of the Study: • What? The primary endpoint is the frequency of pathological echocardiographic findings that lead to a relevant change in intensive care management. • When? The primary endpoint is determined within 24 hours after focused transthoracic echocardiography (TTE). • How? Measurement Method: - TTE findings are systematically recorded in the case report form (CRF) using predefined parameters (e.g., EF, TAPSE, PAPsys, pericardial effusion, pleural effusion, volume status, valvular pathologies). - It is documented whether a pathological finding was detected. Documentation & Evaluation: - The documented findings are compared with subsequent intensive care measures. - A therapy adjustment is only considered relevant if it is directly attributable to the TTE findings. Clinical Measures Following TTE: - Modified ventilation strategy (e.g., transition to ITN/NIV/High-Flow or modification of PEEP settings). - Advanced hemodynamic monitoring (e.g., insertion of a central venous catheter, pulse contour analysis). - Initiation or modification of catecholamine therapy (norepinephrine, dobutamine, adrenaline). - Indication for further diagnostics (e.g., CT, chest X-ray, laboratory parameters such as troponin or D-dimers). - Indication for therapeutic interventions (e.g., pleural puncture, pericardial puncture, diuretic therapy, volume administration, afterload reduction, right heart unloading, cardioversion) Statistical Analysis of the Primary Endpoint: • The rate of pathological echocardiographic findings will be reported as absolute and relative frequency. • The number of patients with a therapy adjustment based on these findings will also be recorded. • Comparison of patients with and without pathological findings regarding changes in clinical therapy (Chi-square test or Fisher’s exact test for categorical data). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints and Their Assessment: 1. Change in Ventilation Regimen Due to TTE Findings - When? Within 24 hours after TTE - How? Documentation of whether the type of ventilation changed due to TTE results: - Transition between ITN, NIV, High-Flow, O2 insufflation - Adjustment of ventilation parameters (e.g., PEEP, FiO2) 2. Expansion of Hemodynamic Monitoring Due to TTE Findings - When? Within 24 hours after TTE - How? Recording of additional monitoring measures performed: - Arterial access - Placement of a central venous catheter - Pulse contour analysis - Indication for transesophageal echocardiography 3. Modification of Catecholamine Therapy Due to TTE Findings - When? Within 24 hours after TTE - How? Comparison between planned and actual catecholamine therapy: Norepinephrine, dobutamine, adrenaline (newly initiated or dose modified) 4. Indication for Further Diagnostics Due to TTE Findings - When? Within 24 hours after TTE -How? Comparison between planned and conducted diagnostics (e.g., CT, chest X-ray, troponin, D-dimers, blood culture, PCT, extended sonography) 5. Indication for Therapeutic Interventions Due to TTE Findings - When? Within 24 hours after TTE - How? Documentation of planned vs. performed interventions: - Pleural puncture - Pericardial puncture - Coronary angiography - CPAP - Administration of diuretics/fluids - Anticoagulation / preload or afterload reduction Statistical Analysis of Secondary Endpoints: • Comparison of patients with and without therapy adjustment due to TTE findings • Descriptive analysis (absolute and relative frequencies) • Group comparison using Chi-square test or Fisher’s exact test | — |
Countries
Germany
Contacts
Klinikum Fürth, Klinik für Anästhsie, Operative Intensivmedizin und Schmerztherapie