Validation of Ballistocardiographic Biosensors and Other Hemodynamic Measures for Healthy Subjects

NCT04585568 | Completed

• 1 other identifier: 153368
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamics; Biosensors; Cardiac

Keywords

blood flow; correlations; ballistocardiography; invasive blood pressure; cardiac output; doppler eccocardiography

Outcome Measures

Primary Outcomes (1)

• Correlation between different measures of hemodynamics

  Calculated based on a number of hemodynamic measures listed in the protocol

  September to December

Interventions

Biosensors OTHER

Measures of blood flow and preassures

Also known as: FloTrac, Doppler eccocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Paramedic students recruited free of will.

You may qualify if:

• Healthy subjects who have signed informed consent

You may not qualify if:

• Sick subjects at test day

Sponsors & Collaborators

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

Study Sites (1)

Oslo University Hospital

Oslo, Please Select, 0367, Norway

Location

MeSH Terms

Interventions

Biosensing Techniques

Intervention Hierarchy (Ancestors)

Molecular Probe Techniques; Investigative Techniques

Study Officials

• Lars Wik, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 14, 2020
• Study Start: September 28, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From September 2020 to September 2025
• Access Criteria: A secure sharing plattform will be used.

Locations

NO (1)