Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167596
Status:
TERMINATED
Last Update Posted:
2016-07-20
First Post:
2005-09-09
Brief Title:
Near Infrared Spectroscopy NIRS in Severe Sepsis
Sponsor:
University of Versailles
Organization:
University of Versailles
Study Overview
Official Title:
Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment was stopped as consequence of cessation of funding economic crisis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OTO-STS
Brief Summary:
The purpose of this study is to evaluate the usefulness of an optimization of muscle perfusion and oxygenation as assessed by the NIRS technique in critically ill patients with sepsis
Detailed Description:
The systemic inflammatory response to sepsis may cause impaired tissue oxygenation that can persist despite the restoration of a normal hemodynamic profile and systemic oxygen transport
Therefore the assessment of tissue oxygenation and perfusion is recommended in patients with severe sepsis
The InSpectra tissue spectrometer relies on continuous wave near infrared NIR technology to estimate non invasively local tissue hemoglobin oxygen saturation in tissue StO2 This technology had been tested in a variety of systems standard theoretical models of light transport isolated blood isolated blood-perfused animal organs and healthy human volunteers with induced limb ischemia In critical-care medicine NIRS has also been used to evaluate muscle oxygenation in trauma resuscitation and in lower extremity and abdominal compartment syndrome However NIRS has been rarely utilised to measure tissue blood flow and oxygen uptake in critically ill patients
Therefore the assessment of tissue oxygenation and perfusion is recommended in patients with severe sepsis
The InSpectra tissue spectrometer relies on continuous wave near infrared NIR technology to estimate non invasively local tissue hemoglobin oxygen saturation in tissue StO2 This technology had been tested in a variety of systems standard theoretical models of light transport isolated blood isolated blood-perfused animal organs and healthy human volunteers with induced limb ischemia In critical-care medicine NIRS has also been used to evaluate muscle oxygenation in trauma resuscitation and in lower extremity and abdominal compartment syndrome However NIRS has been rarely utilised to measure tissue blood flow and oxygen uptake in critically ill patients
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