CompletedNot Applicable

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

Norway183 participantsStarted 2021-05-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

End tidal partial pressure of CO2 (EtCO2).

Timeframe: Day 1

Trial details

NCT IDNCT04891380

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-03

View on ClinicalTrials.gov More Cardiac Arrest, Out-Of-Hospital trials