Shock, cardiovascular failure, cardiac failure Shock, cardiovascular failure, heart failure
Conditions
Interventions
The new device being investigated in this study is called the Starling SV®. It works with four adhesive sensors similar to the ECG electrodes used to measure heart rate. These four sensors are placed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: Admitted to the NICUGestational age at birth between 26 and 42 weeksInformed consent obtained from parents or representatives
Exclusion criteria
Exclusion criteria: Life-threatening congenital disorders.Congenital heart defects, except for patent ductus arteriosus (PDA) and patent foramen ovale (PFO).Skin disorders.High-frequency oscillatory (HFO) ventilationSevere thoracic edema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures are cardiac output and stroke volume, assessed using two different methods: the new device and cardiac ultrasound.Accuracy and precision of the measurements: This includes the mean difference, limits of agreement, and margin of error.Ability to track changes in cardiac output: This is evaluated using the concordance rate, mean angular bias, radial limits of agreement, and angular concordance rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Agreement between clinically estimated cardiac output categories and cardiac output measured by ultrasound: This is assessed using sensitivity and specificity. | — |
Countries
Netherlands
Contacts
Public ContactWP Boode
Radboud Universitair Medisch Centrum
Outcome results
None listed