Ignite Creation Date:
2024-05-06 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03525691
Status:
TERMINATED
Last Update Posted:
2023-12-12
First Post:
2018-05-03
Brief Title:
Enhanced Lung Protective Ventilation With ECCO2R During ARDS
Sponsor:
Hôpital Européen Marseille
Organization:
Hôpital Européen Marseille
Study Overview
Official Title:
Enhanced Lung Protective Ventilation With Extracorporeal CO2 Removal During Acute Respiratory Distress Syndrome
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVE
Brief Summary:
Acute Respiratory Distress Syndrome ARDS is associated with a mortality rate of 30 - 45 and required invasive mechanical ventilation MV in almost 85 of patients1 During controlled MV driving pressure ie the difference between end-inspiratory and end-expiratory airway pressure depends of both tidal volume and respiratory system compliance Either excessive tidal volume or reduced lung aeration may increase the driving pressure ARDS patients receiving tidal volume of 6 mlkg predicted body weight PBW and having a day-1 driving pressure 14 cmH2O have an increased risk of death in the hospital2 Seemly in the LUNG SAFE observational cohort ARDS patients having a day-1 driving pressure 11 cmH2O had the lowest risk of death in the hospital1 Hence driving pressure acts as a major contributor of mortality in ARDS and probably reflects excessive regional lung distension resulting in pro-inflammatory and fibrotic biological processes Whether decreasing the driving pressure by an intervention change mortality remains an hypothesis but one of means is to decrease the tidal volume from 6 to 4 ml kg predicted body weight PBW However this strategy promotes hypercarbia at constant respiratory rate by decreasing the alveolar ventilation In this setting implementing an extracorporeal CO2 removal ECCO2R therapy prevents from hypercarbia A number of low-flow ECCO2R devices are now available and some of those use renal replacement therapy RRT platform The investigators previously reported that combining a membrane oxygenator 065 m² within a hemofiltration circuit provides efficacious low flow ECCO2R and blood purification in patients presenting with both ARDS and Acute Kidney injury3
This study aims to investigate the efficacy of an original ECCO2R system combining a 067 m² membrane oxygenator Lilliput 2 SORIN inserted within a specific circuit HP-X BAXTER and mounted on a RRT monitor PrismafleX BAXTER Such a therapy only aims to provide decarboxylation but not blood purification and has the huge advantage to be potentially implemented in most ICUs without requiring a specific ECCO2R device The study will consist in three periods
The first period will address the efficacy of this original ECCO2R system at tidal volume of 6 and 4 mlkg PBW using an off-on-off design
The second part will investigate the effect of varying the sweep gas flow 0-2-4-6-8-10 lmin and the mixture of the sweep gas AirO2 on the CO2 removal rate
The third part will compare three ventilatory strategies applied in a crossover design
1 Minimal distension Tidal volume 4 mlkg PBW and positive end-expiratory pressure PEEP based on the ARDSNet PEEPFiO2 table ARMA
2 Maximal recruitment 4 mlkg PBW and PEEP adjusted to maintain a plateau pressure between 23 - 25 cmH2O
3 Standard Tidal volume 6 mlkg and PEEP based on the ARDSNet PEEPFiO2 table ARMA
This study aims to investigate the efficacy of an original ECCO2R system combining a 067 m² membrane oxygenator Lilliput 2 SORIN inserted within a specific circuit HP-X BAXTER and mounted on a RRT monitor PrismafleX BAXTER Such a therapy only aims to provide decarboxylation but not blood purification and has the huge advantage to be potentially implemented in most ICUs without requiring a specific ECCO2R device The study will consist in three periods
The first period will address the efficacy of this original ECCO2R system at tidal volume of 6 and 4 mlkg PBW using an off-on-off design
The second part will investigate the effect of varying the sweep gas flow 0-2-4-6-8-10 lmin and the mixture of the sweep gas AirO2 on the CO2 removal rate
The third part will compare three ventilatory strategies applied in a crossover design
1 Minimal distension Tidal volume 4 mlkg PBW and positive end-expiratory pressure PEEP based on the ARDSNet PEEPFiO2 table ARMA
2 Maximal recruitment 4 mlkg PBW and PEEP adjusted to maintain a plateau pressure between 23 - 25 cmH2O
3 Standard Tidal volume 6 mlkg and PEEP based on the ARDSNet PEEPFiO2 table ARMA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None