The objective of this trial is to investigate the feasibility and safety of helium ventilation post cardiac arrest.
ID
Source
Brief title
Condition
- Other condition
- Coronary artery disorders
- Central nervous system vascular disorders
Synonym
Health condition
Status na reanimatie ivm circulatiestilstand
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint will be the occurrence of adverse events due to helium
ventilation. This is defined as death or the necessity to stop ventilation
using helium. The safety committee of this study will judge whether the adverse
events occurred due to helium ventilation or had another cause..
Secondary outcome
Neurological: biomarkers for cerebral damage (neuron specific enolase levels 24
and 48 hours after admission), neurological outcome 30 after admission, as
measured using the Glasgow outcome scale.
Cardiological: biomarkers of myocardial damage ( troponine-T, CK, CK-MB )
assessment cardiac injury by echocardiography ( in the first 72 hours after
admission and at day 30).
Pulmonary: Bloodgasanalysis, veneus saturation and settings of the ventilator
during the first 6 hours.
Background summary
Even after a successful resuscitation after cardiac arrest, 50% of the patients
admitted to the ICU die. Since most patients die due to brain damage sustained
during the ischemia and reperfusion during the event and subsequent restoration
of the circulation, neuroprotective strategies are needed. In animal
experiments, helium inhalation during reperfusion has been shown to reduce the
size of cerebral infarction. Since helium has no known side effects, this might
be an attractive strategy for reducing neurological damage. We hypothesize that
helium ventilation post-resuscitation is both safe and feasible.
Study objective
The objective of this trial is to investigate the feasibility and safety of
helium ventilation post cardiac arrest.
Study design
A single centre open-label intervention trial.
Intervention
Participants will be ventilated using a helium-oxygen gas mixture, with a FiO2
of 40-50%, during the first 3 hours after inclusion in the study.
Study burden and risks
The safety and feasibility of ventilating patients after CPR can only be
investigated in this group. We expect that no adverse events due to helium
ventilation will occur, all assessments needed for this study are part of
standard patient care. A participating patient will not benefit directly from
this treatment, but potentially helium ventilation may have a neuro- and
cardioprotective effect. If helium ventilation turns out to be safe and
feasible, a larges study investigating effectiveness will be conducted in
patients after CPR
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- Admission to the ICU after successful resuscitation after witnessed out-of-hospital cardiac arrest
- Post-anoxic coma on admission
- First registered rhythm ventricular fibrillation (VF) or ventricular tachycardia (VT)
- Return of spontaneous circulation within 30 minutes of arrest
- Ability to start study medication within 6 hours after arrest
- Treatment with induced mild hypothermia
Exclusion criteria
- No informed consent
- Co-morbidity with a life expectancy of <6 months prior to cardiac arrest
- Pregnancy
- Neurological disorder prior to cardiac arrest
- Severely disabled prior to arrest
- A pulmonary condition requiring ventilation with a FiO2 >50% and > 10 cm H2O PEEP at the time of inclusion.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2009-017499-26-NL |
| CCMO | NL30466.018.09 |