Ignite Creation Date:
2024-05-06 @ 9:31 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT03004885
Status:
TERMINATED
Last Update Posted:
2018-03-13
First Post:
2016-12-14
Brief Title:
Enhanced Lung Protective Ventilation for ARDS Patients With PrismaLung
Sponsor:
Hôpital Européen Marseille
Organization:
Hôpital Européen Marseille
Study Overview
Official Title:
Enhanced Lung Protective Ventilation for ARDS Patients With PrismaLung
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient CO2 removal obtained with the PrismaLung membrane oxygenator
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVAP
Brief Summary:
Acute Respiratory Distress Syndrome ARDS still remains associated with a mortality rate of 30 - 45 despite improvement in mechanical ventilation Driving pressure defined as the difference between the end-inspiratory and the end-expiratory airway pressure appears as an important factor contributing to mortality in patients with the ARDS In patients already receiving a conventional tidal volume of 6 mlkg predicted body weight PBW a driving pressure 14 cmH2O increases the risk of death in the hospital One mean to lower the driving pressure is to decrease the tidal volume such that from 6 to 4 mlkg predicted body weight However this strategy promotes hypercarbia by reducing the alveolar ventilation providing the respiratory rate is constant In this setting implementing an extracorporeal CO2 removal ECCO2R therapy may offset the associated hypercarbia The investigators have previously demonstrated that combining a membrane oxygenator within an hemofiltration circuit provides efficacious low flow ECCO2R on a renal replacement therapy monitor In this study we thought to investigate the efficacy of the PrismaLung stand-alone therapy Using a PrismaFlex monitor and a HP-X circuit a neonatal membrane oxygenator PrismaLung is used to provide decarboxylation without renal replacement therapy The study will consist in three periods
The first period will address the efficacy of the PrismaLung device at tidal volume of 6 and 4 mlkg PBW using an off-on-off design
The second part of the study will investigate the effect of varying the sweep gas flow and the mixture of the sweep gas on the CO2 removal rate random order
The third part will compare three ventilatory strategies applied in a cross-over 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
Each strategies will be apply in a random order for a duration of 22 hours Pulmonary inflammatory and fibrosis pathway will be assess before and after each period using bronchoalveolar lavage BAL samples Systemic inflammatory cytokines will also be investigate Main measurements will include respiratory mechanics transpulmonary pressure work of breathing end-expiratory lung volume and tidal ventilation using electrical impedance tomography
The first period will address the efficacy of the PrismaLung device at tidal volume of 6 and 4 mlkg PBW using an off-on-off design
The second part of the study will investigate the effect of varying the sweep gas flow and the mixture of the sweep gas on the CO2 removal rate random order
The third part will compare three ventilatory strategies applied in a cross-over 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
Each strategies will be apply in a random order for a duration of 22 hours Pulmonary inflammatory and fibrosis pathway will be assess before and after each period using bronchoalveolar lavage BAL samples Systemic inflammatory cytokines will also be investigate Main measurements will include respiratory mechanics transpulmonary pressure work of breathing end-expiratory lung volume and tidal ventilation using electrical impedance tomography
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