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

NCT04891380 | Completed DMC

• 1 other identifier: 205218
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

blood flow; rosc; cpr process; invasive blood pressure; cardiac output

Outcome Measures

Primary Outcomes (1)

• End tidal partial pressure of CO2 (EtCO2).

  Physiologic parameter EtCO2 is measured in the endotracheal tube.

  Day 1

Secondary Outcomes (4)

• Saturation of cerebral tissue oxymetry (SctO2)

  Day 1

• Ballistocardiographic measurement of stroke volume in the aorta

  Day 1

• Blood pressures

  Day 1

• Cardiac output

  Day 1

Study Arms (4)

Cardiac arrest patients

OTHER

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

Device: LUCAS 2 Active Decompression 2

Hypotension

OTHER

Patients developed or may develope hypotension of non traumatic origin.

Other: Hypotension

Intensive care patient transport

OTHER

Patients who are transported from one intensive department to another.

Other: Intensive care transport

LUCAS 2 Active Decompression

OTHER

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.

Device: LUCAS 2 Active Decompression 2

Interventions

LUCAS 2 Active Decompression 2 DEVICE

Chest compression with active decompression of the chest. Measurement of physiological parameters.

Also known as: FloTrac ™, BCG, Cerebral oximetry

Cardiac arrest patients; LUCAS 2 Active Decompression

Hypotension OTHER

measurement of physiological parameters

Hypotension

Intensive care transport OTHER

Measurement of physiological parameters

Intensive care patient transport

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian Telemedicine: collaborator
• Kopera Norway: collaborator
• Edwards Medical: collaborator
• Stryker Medical: collaborator
• University of Bilbao: collaborator
• University of Stavanger: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Please Select, 0367, Norway

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Hypotension; Shock

Interventions

Hypotension, Controlled

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Lars Wik, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: It is impossible to mask since the devices used must be put on and operated by the responsible crew.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients who meet the inclusion criterias will be eligiable.

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 18, 2021
• Study Start: May 18, 2021
• Primary Completion: January 3, 2024
• Study Completion: January 3, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all patients included. Available for 36 months
• Access Criteria: Data will be shared with University of Bilbao and Stavanger, Stryker, and Edwards

Locations

NO (1)