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BCG Biosensor and Non- and Invasive Monitoring During Emergency Medicine Cases, a Prospective Feasibility Study

Primary Purpose

Cardiac Arrest, Out-Of-Hospital, Hypotension and Shock

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
LUCAS 2 Active Decompression 2
Hypotension
Intensive care transport
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest, Out-Of-Hospital focused on measuring blood flow, rosc, cpr process, invasive blood pressure, cardiac output

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-traumatic cardiac arrest, hypotension, intensive care transport where an attempt of resuscitation and treatment is considered appropriate in patients age ≥18 years.

Exclusion Criteria:

  • Age <18 years.

    • Traumatic cardiac arrest
    • Known pregnancy (can be included in the hypotension group)
    • Victim not to be resuscitated (DNR orders)
    • Internals in prison
    • Included once in the study already
    • Patients too small for LUCAS 2-AD2 < 18.5 cm chest height
    • Patient too big for LUCAS 2-AD2 > 27.3 cm chest height
    • Chest or upper abdomen surgery (Large scars on the chest, only in the CPR group.
    • Sustained Restoration Of Spontaneous Circulation (ROSC) occurring before the LUCAS 2-AD2 can be applied to the patient, such that further CPR is not needed

Sites / Locations

  • Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Cardiac arrest patients

Hypotension

Intensive care patient transport

LUCAS 2 Active Decompression

Arm Description

Cardiac arrest patients receiving cardiopulmonary resuscitation with LUCAS 2 Active Decompression 2.

Patients developed or may develope hypotension of non traumatic origin.

Patients who are transported from one intensive department to another.

The hemodynamic measurements of the cardiac arrest patients in the present study will be compared with the hemodynamic measurements achieved in the previous study NCT02479152.

Outcomes

Primary Outcome Measures

End tidal partial pressure of CO2 (EtCO2).
Physiologic parameter EtCO2 is measured in the endotracheal tube.

Secondary Outcome Measures

Saturation of cerebral tissue oxymetry (SctO2)
Physiologic parameter SctO2 is measured non invasive with Near Infrared spectroscopy.
Ballistocardiographic measurement of stroke volume in the aorta
Physiologic parameter Ballistocardiography measure non invasive the pulse or chest compression wave generated through the aorta.
Blood pressures
Physiologic parameters of Invasive measurement of systolic, diastolic and mean arterial blood pressures.
Cardiac output
Physiologic parameter to measure blood flow generated by the heart with the use of pulse contour waveform technology.

Full Information

First Posted
May 4, 2021
Last Updated
June 4, 2023
Sponsor
Oslo University Hospital
Collaborators
Norwegian Telemedicine, Kopera Norway, Edwards Medical, Stryker Medical, University of Bilbao, University of Stavanger
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1. Study Identification

Unique Protocol Identification Number
NCT04891380
Brief Title
BCG Biosensor and Non- and Invasive Monitoring During Emergency Medicine Cases, a Prospective Feasibility Study
Official Title
Prehospital Use of a Ballistocardiographic Biosensor to Non-invasively and Invasive Pulse Contour Analysis to Monitor Hemodynamics and Blood Flow During Emergency Medicine Cases, a Prehospital Prospective Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Telemedicine, Kopera Norway, Edwards Medical, Stryker Medical, University of Bilbao, University of Stavanger

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In a out of hospital emergency medicine study the investigators will measure hemodynamic effects of implemented treatments for patients with cardiac arrest, hypotension, and intensive care transports. The investigators will use both non-invasive and invasive measuring technology to measure this. Ballistocardiographic biosensors are introduced together with more advanced non-invasive and invasive measurements such as invasive arterial blood pressure with cardiac output calculation and saturation cerebral tissue oxygenation (SctO2). During treatment of cardiac arrest patients the investigators will use a new LUCAS 2 Active Decompression device (LUCAS 2 AD2) and measure different hemodynamic variables.
Detailed Description
Pre-hospital monitoring of vital signs has documented to increase survival. Especially advanced multi-monitoring units have shown to have this impact but they are demanding in use. Low blood pressure/blood flow are frequent in emergency medicine cases and diagnosed by combining clinical evaluation (breathing, circulation, neurology) with biosensor measures of vital signs. Examples of biosensors are ECG, Ballistocardiographic (BCG), End Tidal CO2 (EtCO2), pulse oximetry (SpO2), saturation cerebral tissue oximetry (SctO2), transthoracic impedance (TTI), and invasive arterial pressure measurements such as pulse contour analysis for cardiac output measures. The gold standard for blood flow measurement is cardiac output [Cardiac Output (CO), volume of blood pumped by the heart pr. minute as the product of stroke volume (SV) and heart rate]. Cardiac output may be measured by invasive (thermodilution, Fick method) or noninvasively techniques [oesophageal Doppler, transoesophageal echocardiography, lithium dilatation cardiac output, pulse contour cardiac output (PICCO, Pulse Cardiac Output system, FloTrac ™), partial CO2 rebreathing, thoracic electrical bioimpedance. Pulse contour analysis is based on that the area under the systolic part of the arterial pressure waveform is proportional to the stroke volume (SV). This may limit the optimal goal for monitoring adequately several emergency medicine cases. There is, therefore, a need to develop and evaluate biosensor devices in these situations. BCG biosensors have been introduced and have documented to be useful in monitoring noninvasively vital signs but they have not been used in acute emergency medicine. It has been documented a correlation (r2=0.85) between BCG biosensor and cardiac output measured by Doppler echocardiogram. The biosensor record very subtle rhythmic movements on the patient skin (abdomen and/or neck) and shows a graph which is presented based on filters and custom-made algorithms as continuous hemodynamic variables (heart- and respiration-rates, heart rate variability, and relative stroke volume). BCG piezoelectric biosensors (BGPS) are easy to put on the patient, non-invasive, light (grams), small (2 x 2 cm), and costs are low. They support live streaming with automatic downloads of data. For most other measuring devices this must be done manually post event. With limited time of education and training all personnel prehospitally can deploy the biosensor over the carotid or abdominal aorta. Based on pilots and a validation study comparing two BCG biosensors (accelerometer and piezoelectric) with measures performed by present clinical practise the piezoelectric biosensor is best for use in situations where measures must be instant. In the same validation study, the investigators documented that pulse contour analysis with the latest software upgrade of FloTrac™ system worked well compared with Doppler echocardiography (manuscript in progress, ClinTrialGov). Studies have validated the efficacy of FloTrac ™ with pulmonary artery catheter and found different results. A review article concluded that FloTrac ™ has the possibility to increase patient safety in relation to perioperative hemodynamic monitoring. A comparison of simultaneous Stroke Volume (SV) and Cardiac Output measurements by echocardiography and FloTrac ™ were done in ten mechanically ventilated intensive care patients and showed a correlation between them (SV, y = 0.9545x + 3.3, R2 = 0.98 and for CO, y = 0.9104x + 7.7074, R² = 0.97). Therefore, it is indicated to use this biosensor for out of hospital cases. Although pulse contour analysis is an invasive method, the investigators have experience with invasive arterial access in the doctor car that respond to emergency cases in Oslo since invasive monitoring is the standard. In a pre-hospital observational study performed by the doctor manned car (119-unit) in Oslo and Akershus, the investigators will compare and document (correlations, sensitivities, specificities) biosensor measures to current gold standard measures during cardiopulmonary resuscitation (CPR), hypotension, and intensive care transports. This challenges the current practice because most pre-hospital units responding to emergency medicine cases do not have alternatives to advanced measures. Therefore, the patient is not monitored well enough in addition to that they seldom receive instant guidance according to the effect of treatment. The investigators approach is novel and innovative since it has never been done but the investigators study group have recent experience with performing similar advanced clinical monitoring studies prehospitally. There is a potential that more pre-hospital units will deliver better monitoring and care to more patients with these non- and invasive approaches. Ultimately, better healthcare will be provided. The data captured for the cardiac arrest patients will be compared with data from NCT02479152. If the current project is successful, the investigators plan to implement this technology in a larger scale and may then be able to study potentially improved survival and morbidity rates with sufficient statistical power in future studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Out-Of-Hospital, Hypotension and Shock
Keywords
blood flow, rosc, cpr process, invasive blood pressure, cardiac output

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All patients who meet the inclusion criterias will be eligiable.
Masking
None (Open Label)
Masking Description
It is impossible to mask since the devices used must be put on and operated by the responsible crew.
Allocation
Non-Randomized
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac arrest patients
Arm Type
Other
Arm Description
Cardiac arrest patients receiving cardiopulmonary resuscitation with LUCAS 2 Active Decompression 2.
Arm Title
Hypotension
Arm Type
Other
Arm Description
Patients developed or may develope hypotension of non traumatic origin.
Arm Title
Intensive care patient transport
Arm Type
Other
Arm Description
Patients who are transported from one intensive department to another.
Arm Title
LUCAS 2 Active Decompression
Arm Type
Other
Arm Description
The hemodynamic measurements of the cardiac arrest patients in the present study will be compared with the hemodynamic measurements achieved in the previous study NCT02479152.
Intervention Type
Device
Intervention Name(s)
LUCAS 2 Active Decompression 2
Other Intervention Name(s)
FloTrac ™, BCG, Cerebral oximetry
Intervention Description
Chest compression with active decompression of the chest. Measurement of physiological parameters.
Intervention Type
Other
Intervention Name(s)
Hypotension
Intervention Description
measurement of physiological parameters
Intervention Type
Other
Intervention Name(s)
Intensive care transport
Intervention Description
Measurement of physiological parameters
Primary Outcome Measure Information:
Title
End tidal partial pressure of CO2 (EtCO2).
Description
Physiologic parameter EtCO2 is measured in the endotracheal tube.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Saturation of cerebral tissue oxymetry (SctO2)
Description
Physiologic parameter SctO2 is measured non invasive with Near Infrared spectroscopy.
Time Frame
Day 1
Title
Ballistocardiographic measurement of stroke volume in the aorta
Description
Physiologic parameter Ballistocardiography measure non invasive the pulse or chest compression wave generated through the aorta.
Time Frame
Day 1
Title
Blood pressures
Description
Physiologic parameters of Invasive measurement of systolic, diastolic and mean arterial blood pressures.
Time Frame
Day 1
Title
Cardiac output
Description
Physiologic parameter to measure blood flow generated by the heart with the use of pulse contour waveform technology.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-traumatic cardiac arrest, hypotension, intensive care transport where an attempt of resuscitation and treatment is considered appropriate in patients age ≥18 years. Exclusion Criteria: Age <18 years. Traumatic cardiac arrest Known pregnancy (can be included in the hypotension group) Victim not to be resuscitated (DNR orders) Internals in prison Included once in the study already Patients too small for LUCAS 2-AD2 < 18.5 cm chest height Patient too big for LUCAS 2-AD2 > 27.3 cm chest height Chest or upper abdomen surgery (Large scars on the chest, only in the CPR group. Sustained Restoration Of Spontaneous Circulation (ROSC) occurring before the LUCAS 2-AD2 can be applied to the patient, such that further CPR is not needed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Wik, MD, PhD
Phone
91728966
Email
lars.wik@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Svensøy, MD
Phone
91325026
Email
johannessvensoy@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Wik, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
State/Province
Please Select
ZIP/Postal Code
0367
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Wik, MD
Phone
91728966
Email
lars.wik@medisin.uio.no
First Name & Middle Initial & Last Name & Degree
tore Skaalhegg
Phone
95251068
Email
toretang911@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Sharing will be done using an approved data sharing program
IPD Sharing Time Frame
After all patients included. Available for 36 months
IPD Sharing Access Criteria
Data will be shared with University of Bilbao and Stavanger, Stryker, and Edwards

Learn more about this trial

BCG Biosensor and Non- and Invasive Monitoring During Emergency Medicine Cases, a Prospective Feasibility Study

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