This study evaluates the use of ultra-protective ventilation, where very low ventilation volumes are used, in patients with severe acute respiratory distress syndrome (ARDS) meeting criteria to nurse in the prone position. Half the patients will receive ultra-protective ventilation support by extracorporeal carbon dioxide removal, while the other half will receive conventional lung protective ventilation.
Current best practices for management of severe ARDS include lung protective ventilation and nursing in the prone position. However, the best lung protective strategy is not currently established and using smaller ventilation volumes than standard lung protective ventilation suggest lung recovery is improved. Application of smaller ventilation volumes requires extracorporeal carbon dioxide removal, using a device similar to a dialysis to remove carbon dioxide directly from the blood. One such device in the Prismalung, it removes blood through a catheter, much like a dialysis catheter, pumps it through a gas exchange cartridge which removes carbon dioxide. The gas exchange cartridge functions in a similar way to a dialysis filter, except it allow gases to pass through, unlike dialysis filters which allow passage of fluid and small molecules.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
8
Prism lung (Baxter Healthcare/Gambro Lund, Sweden) is an extracorporeal carbon dioxide removal device. It removes blood through a double lumen catheter and pumps it through a hollow fiber gas exchange cartridge which is impervious to fluid. Carbon dioxide diffuses out, down a concentration gradient which is maintained by sweep gas flowing through the centre of the hollow fibres. The decarboxylated blood is returned to the patient through the double lumen catheter.
Ventilation with \</= 3ml/kg predicted body weight
Ventilation with 6ml/kg predicted body weight
National University Hospital
Singapore, Singapore
Ng Teng Fong General Hospital
Singapore, Singapore
Plateau Pressure
Ability to achieve a plateau pressure of \</=25 cmH20 in the intervention arm
Time frame: Duration of ventilation for severe ARDS, expected average time 10 days
Length of stay in ICU stay
Time frame: Duration of patient stay in ICU, expected average stay 2 weeks
Length of hospital stay
Time frame: Duration of patient stay in hospital
Mortality
ICU mortality, hospital mortality, 30 day, 60 day and 90 day mortality
Time frame: Monitored for 3 months
Cardiac Imaging
Echocardiogram data will be collected before prone position, after prone positioning and following initiation of ultra-protective ventilation
Time frame: One data set per patient during first 72 hours
Extracorporeal carbon dioxide removal related complications
Complications or adverse events related to ECCO2R and associated anticoagulation
Time frame: Duration of severe ARDS, expected average time frame 10 days
Ventilator free days
Time frame: 28 days
All severe adverse events
Time frame: Duration of ICU stay (anticipate average stay 1-2 weeks)
Number of patient meeting proning criteria in each group
Time frame: Duration of ICU stay
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Ability to successfully prone
Time frame: Duration of ICU stay
Incidence of dialysis in ICU, and ability to successfully initiate
Time frame: Duration of ICU stay
Incidence of referrals for ECMO
Time frame: Duration of ICU stay
Rate and reasons for declining consent to study participation
Time frame: First 48 hours
Enrolment rates
Time frame: First 48 hours
Lung recruitability
Time frame: Duration of ICU stay
Ventilation parameters
Data download from mechanical ventilation
Time frame: Duration of mechanical ventilation
Ventilator associated pneumonia rates
Time frame: Duration of ICU stay
Barotrauma complications
Time frame: Duration of ICU stay
Biomarkers of Pulmonary Inflammation
Serum will be drawn and stored for pulmonary biomarkers analysis at the above time points
Time frame: Day 0, 4 and 7