Validation of Ballistocardiographic Biosensors and Other Hemodynamic Measures for Healthy Subjects

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04585568

Collaborator

Norwegian Telemedicine (Other), Kopera Norway (Other), Edwards Lifesciences (Industry), Stryker Medical (Industry), University of the Basque Country (UPV/EHU) (Other), University of Stavanger (Other)

Enrollment

Location

Actual Duration (Days)

304.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamics Biosensors Cardiac	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.

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 28, 2020

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Sep 30, 2020

Outcome Measures

Primary Outcome Measures

Correlation between different measures of hemodynamics [September to December]
Calculated based on a number of hemodynamic measures listed in the protocol

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy subjects who have signed informed consent

Exclusion Criteria:

Sick subjects at test day

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo	Please Select	Norway	0367

Sponsors and Collaborators

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

Investigators

Principal Investigator: Lars Wik, MD, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lars Wik, Principle Investigator, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT04585568

Other Study ID Numbers:

153368

First Posted:

Oct 14, 2020

Last Update Posted:

Oct 14, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lars Wik, Principle Investigator, Oslo University Hospital

blood flow

correlations

ballistocardiography

invasive blood pressure

cardiac output

doppler eccocardiography

Study Results

No Results Posted as of Oct 14, 2020