Validation of Ballistocardiographic Biosensors and Other Hemodynamic Measures for Healthy Subjects

NCT ID: NCT04585568

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2020-09-30

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.

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.

Conditions

Hemodynamics; Biosensors; Cardiac

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Biosensors

Measures of blood flow and preassures

Intervention Type: OTHER

Other Intervention Names

FloTrac; Doppler eccocardiography

Eligibility Criteria

Inclusion Criteria

• Healthy subjects who have signed informed consent

Exclusion Criteria

• Sick subjects at test day

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norwegian Telemedicine

UNKNOWN

Sponsor Role: collaborator

Kopera Norway

UNKNOWN

Sponsor Role: collaborator

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Stryker Medical

INDUSTRY

Sponsor Role: collaborator

University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role: collaborator

University of Stavanger

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lars Wik

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Wik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, Please Select, Norway

Countries

Norway

Other Identifiers

153368

Identifier Type: -

Identifier Source: org_study_id