Clinical trial NCT02252094: Ultra-protective Pulmonary Ventilation Supported by Low Flow ECCO2R for Severe ARDS
Official title: Ultra-protective Pulmonary Ventilation Supported by Low Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) and Prone Positioning for ARDS; a Pilot Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Distress Syndrome, Adult
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2014-09-29
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plateau Pressure
timeFrame: Duration of ventilation for severe ARDS, expected average time 10 days
Secondary outcomes:
measure: Length of stay in ICU stay
timeFrame: Duration of patient stay in ICU, expected average stay 2 weeks
measure: Length of hospital stay
timeFrame: Duration of patient stay in hospital
measure: Mortality
timeFrame: Monitored for 3 months
measure: Cardiac Imaging
timeFrame: One data set per patient during first 72 hours
measure: Extracorporeal carbon dioxide removal related complications
timeFrame: Duration of severe ARDS, expected average time frame 10 days
measure: Ventilator free days
timeFrame: 28 days
measure: All severe adverse events
timeFrame: Duration of ICU stay (anticipate average stay 1-2 weeks)
measure: Number of patient meeting proning criteria in each group
timeFrame: Duration of ICU stay
measure: Ability to successfully prone
timeFrame: Duration of ICU stay
measure: Incidence of dialysis in ICU, and ability to successfully initiate
timeFrame: Duration of ICU stay
measure: Incidence of referrals for ECMO
timeFrame: Duration of ICU stay
measure: Rate and reasons for declining consent to study participation
timeFrame: First 48 hours
measure: Enrolment rates
timeFrame: First 48 hours
measure: Lung recruitability
timeFrame: Duration of ICU stay
measure: Ventilation parameters
timeFrame: Duration of mechanical ventilation
measure: Ventilator associated pneumonia rates
timeFrame: Duration of ICU stay
measure: Barotrauma complications
timeFrame: Duration of ICU stay
measure: Biomarkers of Pulmonary Inflammation
timeFrame: Day 0, 4 and 7
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Ng Teng Fong General Hospital
Study officials:
affiliation: National University Health System
name: Matthew E Cove, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2.
citation: Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.