Respiratory Distress Syndrome, Adult
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPrismalung
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.
OTHERUltra-protective ventilation
Ventilation with \</= 3ml/kg predicted body weight
Ventilation with 6ml/kg predicted body weight
Sponsors
Baxter Healthcare Corporation
National University Health System, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analysis will be blinded.
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Admitted to MICU with respiratory failure and intubated * ARDS criteria per Berlin definition * PaO2:FiO2 ratio ≤ 200 mmHg for \> 6 hours with FiO2 ≥0.5 * Expected to require mechanical ventilation for \>48 hours * Reversible disease
Exclusion criteria
* Anticoagulation contraindicated * Proven HIT * Unable to obtain central venous access * Refractory hypoxia (PaO2:FiO2 ≤80 after recruitment and proning) or other indication for ECMO * Home oxygen use * Severe COPD * Interstitial lung disease * \> 7 days of mechanical ventilation * Immunocompromised patient (bone marrow, untreated HIV, PJP) * Advanced malignancy with life expectancy ≤ 6months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plateau Pressure | Duration of ventilation for severe ARDS, expected average time 10 days | Ability to achieve a plateau pressure of \</=25 cmH20 in the intervention arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Duration of patient stay in hospital | — |
| Mortality | Monitored for 3 months | ICU mortality, hospital mortality, 30 day, 60 day and 90 day mortality |
| Cardiac Imaging | One data set per patient during first 72 hours | Echocardiogram data will be collected before prone position, after prone positioning and following initiation of ultra-protective ventilation |
| Extracorporeal carbon dioxide removal related complications | Duration of severe ARDS, expected average time frame 10 days | Complications or adverse events related to ECCO2R and associated anticoagulation |
| Ventilator free days | 28 days | — |
| All severe adverse events | Duration of ICU stay (anticipate average stay 1-2 weeks) | — |
| Number of patient meeting proning criteria in each group | Duration of ICU stay | — |
| Ability to successfully prone | Duration of ICU stay | — |
| Length of stay in ICU stay | Duration of patient stay in ICU, expected average stay 2 weeks | — |
| Incidence of referrals for ECMO | Duration of ICU stay | — |
| Rate and reasons for declining consent to study participation | First 48 hours | — |
| Enrolment rates | First 48 hours | — |
| Lung recruitability | Duration of ICU stay | — |
| Ventilation parameters | Duration of mechanical ventilation | Data download from mechanical ventilation |
| Ventilator associated pneumonia rates | Duration of ICU stay | — |
| Barotrauma complications | Duration of ICU stay | — |
| Biomarkers of Pulmonary Inflammation | Day 0, 4 and 7 | Serum will be drawn and stored for pulmonary biomarkers analysis at the above time points |
| Incidence of dialysis in ICU, and ability to successfully initiate | Duration of ICU stay | — |
Countries
Singapore
Outcome results
None listed