NCT04585568

Validation of Ballistocardiographic Biosensors and Other Hemodynamic Measures for Healthy Subjects

Completed Last updated 14 October 2020

What this trial tests

trial testing Biosensors in Hemodynamics in 20 participants. Completed in 30 September 2020.

Timeline

28 September 2020

Primary endpoint
30 September 2020

30 September 2020

Quick facts

Lead sponsor	Oslo University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	20
Start date	28 September 2020
Primary completion	30 September 2020
Estimated completion	30 September 2020
Sites	1 location across Norway

Drugs / interventions tested

• Biosensors

Conditions studied

• Hemodynamics — all drugs for Hemodynamics →
• Biosensors — all drugs for Biosensors →
• Cardiac — all drugs for Cardiac →

Sponsor

Oslo University Hospital

Who can join

18 and older, any sex, with Hemodynamics or Biosensors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ballistocardiographic (BCG) biosensors reflecting the patients' current state is established. There are few studies documenting BCG biosensors efficacy, effectiveness, and efficiency. In addition, technologies using invasive blood pressure curves and Near Infrared Regional Spectrometry (NIRS) to measure hemodynamics have been used. Using these technologies to guide clinical decisions may be an major advance for patients with acute and chronic diseases. The investigators will explore how these technologies compares to well established technologies measuring vital signs of healthy subjects. The investigators will use live continuous and non-continuous biosensor data to monitor the development of vital parameters during different scenarios. The study will document how CPD measured by biosensors, cerebral oximetry measured by NIRS, and invasive blood pressure curves measured by FloTrac™ are compared to established technologies of vital organ functionality.

Data will be measured continuously and documented simultanuously with technologies such as Doppler Echocardiography, transthoracic impedance (TTI), Electrocardiogram (ECG), invasive blood pressure \[cardiac output/index (CO/CI), stroke volume/stroke volume index (SV/SVI), stroke volume variation/pulse pressure variation (SVV/PPV), systemic vascular resistance/ systemic vascular resistance index (SVR/SVRI), mean arterial pressure (MAP)\], pulse oximetry (SpO2) and cerebral oximetry (rSO2). Of special interest is to document how relative heart stroke volume reflects blood flow documented by the parallel technology measures. All these measures are the key part in the study to document user friendliness, accuracy, sensitivity, specificity and correlations.

The main research question is whether adding BCG biosensor measures, cerebral oximetry and invasive blood pressure to monitor vital signs will add meaningful information to the care of patients in a situation where we are able to control all the factors that may impact these measures. The aim of the study is to document (correlation, sensitivity and specificity) how BCG biosensors perform compared to each other and to well established technologies used for monitoring blood flow, blood pressure, heart rate and respiration rate in steady state and during ambulance transport. In addition, the investigators will in a controlled manner measure how established maneuvers like Trendelenburg, hypo-/hyperventilation, and bolus of fluid influences our measures.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cardiac output estimation using ballistocardiography: a feasibility study in healthy subjects.
   Svensøy JN, Alonso E, Elola A, Bjørnerheim R, et al · · 2024 · cited 2× · PMID 38238507 · DOI 10.1038/s41598-024-52300-3