Respiratory, hemodynamic and inflammatory effects of induced HypothermiA using NoVAtherm with extra corporeal membrane ventilator iLA-Activve in patients with acute respiratory distress syndrome (ARDS)

Acute respiratory distress syndrome (ARDS) develops in 30-60% of critically ill
patients admitted to the Intensive Care. ARDS is characterized by an
inflammatory response, often requiring mechanical ventilation with high
pressures, causing additional damage. Also, right ventricular dysfunction is a
common finding in ARDS, contributing to mortality. Reduction in pulmonary
compliance during ARDS may require application of high pressure levels to
maintain adequate ventilation, which can reduce cardiac output or even result
in the development of obstructive shock.

The iLA-Activve MinilungTM (artificial lung) is a veno-venous support system
that can effectively eliminate CO2. To a lesser extend, it can also oxygenate
blood. Induced hypothermia reduces metabolic rate with a concomitant lower CO2
production, allowing for lower minute volume ventilation for adequate
decarboxylation. In combination, this device has a strong potential to reduce
minute volume ventilation while maintaining adequate gas exchange in ARDS,
thereby reducing peak pressures, with subsequent reduction in lung injury.
Also, use of iLAartifical lung may favour hemodynamic parameters

Primary Objective:
Does induced hypothermia using NovathermTM combined with the iLA-Activve
MinilungTm result in a reduction in minute volume ventilation and work of
breathing by reducing positive peak inspiratory pressure levels in patients
with ARDS?

Secondary Objectives:
1) Does induced hypothermia using NovathermTM with iLA-Activve MinilungTM
increase cardiac output and mean arterial pressure (or reduce vasopressor need)
by improving loading conditions in patients with ARDS?
2) Does induced hypothermia using NovathermTM with iLA-Activve MinilungTM
attenuate lung injury in patients with ARDS?

Randomized controlled open label trial in mechanically ventilated patients,
admitted at the Intensive Care Unit with ARDS. Patients will be randomized to
one of the following groups:
1) Use of iLA-Activve MinilungTM in combination with NovathermTM with cooling
to 32-34 ºC during 12 hours;
2) Use of iLA-Activve MinilungTM while maintaining normotemperature during 12
hours;
3) Standard care.

Randomized controlled open label trial in mechanically ventilated patients,
admitted at the Intensive Care Unit with ARDS. Patients will be randomized to
one of the following groups:
1) Use of iLA-Activve MinilungTM in combination with NovathermTM with cooling
to 32-34 ºC during 12 hours;
2) Use of iLA-Activve MinilungTM while maintaining normotemperature during 12
hours;
3) Standard care.

To connect the iLA-Activve Minilung device, a double lumen cannula of 18 French
Gauge will be inserted in the jugular or femoral vein under ultrasound
guidance. Participants will undergo an echocardiography (3x) and SDF (3x).
These investigations are non-invasive. Participants will donate a total of 30
ml of blood, drawn from a catheter already in place. Patients will undergo a
minilunglavage, which is a minimal burden and is also done as part of routine
airway management on our ICU.

Risks related to the artificial lung:
Thrombus/Embolus
bleeding with possible blood transfusion
ischemia of the cannulated leg
These complications occur in < 2%

Risks related to hypothermia:
electrolyte disturbances
bradycardia
These complications are wellknown, anticipated, checked and treated.

Risks related to this study are justified because of their low incidence.
Interventions are part of the routine care on the ICU (hypothermia,
catherisation en anticoagulation).
Included patients may experience a possibly therapeutic effect, because the
artifical lung will allow for lowering of ventilation pressures, thereby
possibly lowering lung injury. Also the right ventricle may experience a
beneficial effect.