In this study, we aim to improve survival to hospital discharge and costs/QALY in young patients with OHCA by decreasing the time in cardiac arrest by initiating ECPR on scene.
ID
Source
Brief title
Condition
- Heart failures
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hospital survival and costs/QALY (EQ-D5), favourable neurological outcome (CPC
1-2) at 6 and 12 months after cardiac arrest.
Secondary outcome
To study the health care costs per OCHA patient (iPCQ, iMCQ), costs per Quality
Adjusted Life Year (QALY), Quality of life 6 and 12 months after OHCA and total
costs per life gained in the intervention group and in the control group
Background summary
Approximately half of all cardiac arrest patients achieve return of
spontaneous circulation (ROSC) within 10 minutes. However, If ROSC is not
achieved within 20 minutes, favourable neurological outcome is rare. Nowadays,
patients without ROSC at scene, die at scene, or are transported (while in
cardiac arrest) to the hospital. In the hospital, advanced life support is
continued, or, patients receive Extracorporeal CardioPulmonary Resuscitation
(ECPR). ECPR is a strategy in which a miniaturized heart-lung machine (similar
to that used in open-heart surgery) is attached to the patient. Nowadays, the
greatest drawback transporting OHCA patients with refractory arrest to the
hospital is the long time needed to arrive in the hospital. In the Netherlands,
Helicopter Emergency Medical Services (HEMS) deliver highly specialized medical
care to trauma and non-trauma patients, covering the entire country. We
hypothesize that implantation of on-scene ECPR by the HEMS teams in patients
with out-of-hospital cardiac arrest, results in the rapid return of circulation
and, thus, improved survival and less neurological impairment, which is
associated with lower health care costs.
Study objective
In this study, we aim to improve survival to hospital discharge and costs/QALY
in young patients with OHCA by decreasing the time in cardiac arrest by
initiating ECPR on scene.
Study design
Multicenter, stepped-wedge trial, comparing deployment of HEMS not equipped
with ECPR with HEMS equipped with ECPR in patients with a witnessed
out-of-hospital cardiac arrest between the age of 18 and 50 years old.
Intervention
Initiation of ECPR prehospital, delivered by the HEMS teams. In the control
group, HEMS teams will provide Advanced Life Support following the national
guidelines.
Study burden and risks
The potential benefits for patients who are included in this study is that
additional medical expertise is added, in the control group and intervention
group. Moreover, in the intervention group, early termination of the cardiac
arrest state by mechanically restoring bloodflow will most probably result in
an improved survival. On the other hand, potential risks are the inability of
cannulation in ongoing cardiac arrest, and vascular complications. These risks
are minimalized by a very extensive training program as shown by a pilot
performed at Erasmus MC. Moreover, multiple studies have shown that ECPR
cannulation by intensivist in the hospital or pre-hospital performed by
emergency physicians is safe and feasible. Despite the training, multiple
studies, as well as data from the ErasmusMC, still show a 10% inability of
cannulation rate and a 10% vascular complications rate. Despite of the
complication rate, this study has probably major survival benefits for the
patients to participate, which outweighs the potential risks.
Dr Molewaterplein 40
Rotterdam 3015GD
NL
Dr Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- Age between 18 and 50 years
- Witnessed arrest (last seen well <5 min), OR signs of life (gasping, movement)
- Initial rhyme is VT/VF OR Suspected of having a pulmonary embolism
- Refractory cardiac arrest lasting longer than 20 minutes and shorter than 45
min
Exclusion criteria
- CO2 et<1.2 kPa (10 mmHg) during CPR
- No clear echographic visualisation of either the femoral artery or the
femoral vein.
- Expected time from collapse to arrival at an ECPR center with a direct
available ECPR team is less than 30 min.
- Patients from a dispatch region which is not ready to deploy HEMS on a
routine basis for OHCA patients with the age between 18 and 50 years.
The following patients will be withdrawed after initial inclusion as soon as
the following information becomes available:
- Known malignancy
- Known intracranial haemorrhage/ischemia <6 weeks
- Care dependent for daily activities before arrest
- Patients with a *do not resuscitate* order, which was not known at time of
the arrest.
- Refusal of defferred consent by the next of kin or by the patient himself to
use the data.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04620070 |
| CCMO | NL73073.078.20 |