Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04891380 |
| Other study ID # |
205218 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 18, 2021 |
| Est. completion date |
January 3, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Oslo University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
