Shock. Heart failure. Shock. Heart failure.
Conditions
Interventions
The product under devolpment is called Photonic Temperature Sensing System Functional Model. This product will not be used for collecting data in this study however. The investigational product being
Sponsors
Catharina Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults, being 18 years or older, undergoing standardized invasive coronary function testing, with a left ventricular ejection fraction of 50% or more.
Exclusion criteria
Exclusion criteria: Being in a clinical state of shock, defined as having one of the following clinical parameters:Systolic blood pressure of 90 mmHg or lower.Continuous resting heart rate of 100 beats per minute or higher.Urine output of 0.5 milliliter per kilogram per hour or less.If available an arterial lactate level of 3 millimole per liter or higher.Being in a state of decompensated heart failure as established by clinical examination and need for oxygen suppletion.Having a severe cardiac valve stenosis or insufficiency.Having a congenital cardiac disease.Having severe hypertension, defined as a systolic blood pressure of 200 mmHg or higher and/or a diastolic blood pressure of 120 mmHg or higher.Being in a state of high cardiac output, defined as a continuous resting heart rate of 100 beats per minute or higher and/or (if available) a cardiac index of 4 liter per minute per square meter body surface or higher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter will be a reproducible thermal indicator dilution curve. | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine the impact of physiological/external temperature variations on the indicator dilution curve. | — |
Countries
Netherlands
Contacts
Public ContactB.C.J.H. Mulders
Catharina Ziekenhuis
Outcome results
None listed