NCT02252094

Ultra-protective Pulmonary Ventilation Supported by Low Flow ECCO2R for Severe ARDS

Ultra-protective Pulmonary Ventilation Supported by Low Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) and Prone Positioning for ARDS; a Pilot Study.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: National University Health System, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome, Adult

Interventions

Type	Name	Description
DEVICE	Prismalung	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.
OTHER	Ultra-protective ventilation	Ventilation with \</= 3ml/kg predicted body weight
OTHER	Conventional Lung Protective Ventilation	Ventilation with 6ml/kg predicted body weight

Timeline

• Start date: 2017-05-22
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2014-09-29
• Last updated: 2020-09-14

Locations

2 sites across 1 country: Singapore