Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435110
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2007-02-12
Brief Title:
Effects of PEEP and FIO2 in ALI and ARDS
Sponsor:
Instituto Canario de Investigacion Biomedica
Organization:
Instituto Canario de Investigacion Biomedica
Study Overview
Official Title:
Effects of PEEP and FiO2 in the Evaluation of Severity of ALI and ARDS
Status:
COMPLETED
Status Verified Date:
2018-10
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:
HELP
Brief Summary:
Current American-European Consensus Conference AECC definitions for ALI and ARDS are inadequate for inclusion into clinical trials due to the lack of standardization for measuring the oxygenation defect We questioned whether an early assessment of oxygenation on specific ventilator settings would identify patients with established ARDS persisting over 24h
Detailed Description:
We designed this study to determine whether standard ventilator settings applied on the day ARDS is identified Day 0 or 24 hours Day 1 later 1 would have an impact on the reclassification of patients into ALI or ARDS and 2 would identify groups with different clinical outcomes Our hypothesis was that the assessment of PaO2FiO2 on standard ventilator settings 24 hours after patients originally met the AECC definition of ARDS would identify patients with established ARDS persisting over 24 h from others with different degrees of lung injury If this hypothesis is supported it would suggest that patients with a better outcome could have been preferentially entered into one group of previously conducted clinical trials resulting in a viable therapy being proved useless or useless therapy proven viable
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