NCT04648293

Starling Registry Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,207 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes. Being able to precisely and rapidly determine patient fluid responsiveness provides the bedside physician and nursing staff the information needed to make critical decisions in regards to the patient's fluid status and management of additional fluids and medications. As fluid management and cardiac output determination are linked to better decision-making and improved outcomes in ICU, the use of a dynamic assessment of fluid responsiveness becomes a key tool for patient management. This study is designed to collect treatment and outcome data on patients that have undergone hemodynamic monitoring in a wide variety of clinical settings, involving a variety of patient diagnoses.

Conditions

• Hemodynamic Monitoring

Interventions

Type	Name	Description
DEVICE	Starling	Starling is a portable, non-invasive, cardiac output detector system. The Starling monitor measures the cardiac output by employing electrical bioreactance that measures the electrical characteristics of a volume of tissue and fluid. In the case of cardiac output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood. Baxter Healthcare's Starling electrode is a double electrode sensor. Within each sensor, one electrode is used to transmit a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. Four electrodes are placed at specific areas of the thorax, the impedance to the current flow calculated, and the electrical bioreactance waveform constructed. This information is used to determine cardiac output, and measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Starling device.

Timeline

• Start date: 2020-11-16
• Primary completion: 2024-02-21
• Completion: 2024-02-21
• First posted: 2020-12-01
• Last updated: 2024-04-16

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study