Ignite Creation Date:
2024-05-06 @ 7:50 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02606240
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2015-11-11
Brief Title:
Low-Flow CO2 Removal for Mild to Moderate ARDS With PRISMALUNG
Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Organization:
Groupe Hospitalier Pitie-Salpetriere
Study Overview
Official Title:
Extracorporeal CO2 Removal ECCO2R With a Renal Replacement Platform PRISMALUNG to Enhance Lung Protective Ventilation in Patients With Mild to Moderate Acute Respiratory Distress Syndrome ARDS
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot observational study will assess changes in pH PaO2 PaCO2 Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal ECCO2R following tidal volume Vt and plateau pressure reduction in patients with mild to moderate ARDS
Detailed Description:
Extracorporeal CO2 removal ECCO2R with a low-flow CO2 removal device Prismalung Gambro-Baxter integrated on the Prismaflex platform Gambro-Baxter allows tidal volume Vt and plateau pressure reduction in patients with mild to moderate ARDS This pilot observational study will assess changes in pH PaO2 PaCO2 Respiratory Rate and device CO2 clearance in the first 24 hours of ECCO2R following Vt and plateau pressure reduction in patients with mild to moderate ARDS Safety variables during treatment will also be analyzed A series of 20 consecutive patients will be included in this observational study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None