Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04692129
Status:
UNKNOWN
Last Update Posted:
2022-07-28
First Post:
2020-12-30
Brief Title:
Prone Positioning Short-term Effects on Tissue Oxygen Saturation in Critical COVID-19 Patients
Sponsor:
Corporacion Parc Tauli
Organization:
Corporacion Parc Tauli
Study Overview
Official Title:
Short-term Effects of Prone Positioning on Tissue Oxygen Saturation Measured by Near-infrared Spectroscopy in COVID-19 Patients With Acute Respiratory Distress Syndrome
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
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:
PRONECOVID19
Brief Summary:
The purpose of this study is to monitor short-term changes in tissue oxygen saturation and local blood flow as results of changing from supine to prone position in ARDS COVID-19 patients
Detailed Description:
After obtaining consent to participate in the study the subjects included in the study will undergo a baseline 15-minute measurement of tissue oxygen saturation StO2 measured non-invasively on the forearm by means of near-infrared spectroscopy NIRS Once a baseline stable StO2 value is obtained a provocative test consisting of a transient vascular occlusion will be performed The test will allow the obtention of a local metabolic rate and a StO2 recovery rate after the ischemic stimulus
Tissue oxygenation measurements will be performed in supine position immediately before changing to prone positioning and repeated after 20 minutes of stabilization once in prone position
Tissue oxygenation measurements will be performed in supine position immediately before changing to prone positioning and repeated after 20 minutes of stabilization once in prone position
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?:
False
Is an FDA AA801 Violation?:
None