Validation of Ballistocardiographic Biosensors and Other Hemodynamic Measures for Healthy Subjects

Validation and Comparison of Ballistocardiographic Biosensors and Other Hemodynamic Measures for Healthy Subjects During Different Situations

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamics; Cardiac; Biosensors
• Intervention / Treatment: Other: Biosensors

Detailed Description

Ballistocardiographic (BCG) biosensors collecting continuous physiological data (CPD) in real time to generate information reflecting the patients' current state is established and have become more useful in monitoring vital signs of subjects and patients. There are few studies documenting BCG biosensors efficacy, effectiveness, and efficiency. Using CPD to guide clinical decisions may be a major advance for patients with acute and chronic diseases. In addition, technologies using invasive blood pressure curves and Near Infrared Regional Spectrometry (NIRS) to measure hemodynamics have been used. This may drive the evolution from episodic to continuous patient care for these patients experiencing a severe medical event compromising blood flow. The investigators will explore how these technologies compares to well established technologies measuring vital signs of healthy subjects. In the present study 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 FloTracTM are compared to established technologies of vital organ functionality.

In the present study data will be measured continuously and in phases of the study simultaneously with other well established 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). Based on this the investigators believe they will be able to pick up how dynamic differences develop. Of special interest is to document how relative heart stroke volume reflects blood flow documented by the parallel technology measures. HRV will also be evaluated in the light of other measures such as pulse, respiration, and relative stroke volume. 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Norway
  • Please Select
    • Oslo, Please Select, Norway, 0367
      • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Paramedic students recruited free of will.

Description

Inclusion Criteria:

• Healthy subjects who have signed informed consent

Exclusion Criteria:

• Sick subjects at test day

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between different measures of hemodynamics	Calculated based on a number of hemodynamic measures listed in the protocol	September to December

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of the Basque Country (UPV/EHU); Edwards Lifesciences; Stryker Medical; University of Stavanger; Norwegian Telemedicine; Kopera Norway

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2020
• Primary Completion (ACTUAL): September 30, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: invasive blood pressure; cardiac output; blood flow; correlations; ballistocardiography; doppler eccocardiography
• Other Study ID Numbers: 153368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Based on informed consent this will be done with those parties listed.
• IPD Sharing Time Frame: From September 2020 to September 2025
• IPD Sharing Access Criteria: A secure sharing plattform will be used.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No