Viewing Study NCT01174966


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Study NCT ID: NCT01174966
Status: UNKNOWN
Last Update Posted: 2010-08-04
First Post: 2010-08-02
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Assessment of Transcutaneous Oxygen Tension/Oxygen Challenge Test in Intensive Care Unit (ICU) Patients
Sponsor: Peking Union Medical College Hospital
Organization:

Study Overview

Official Title: Assessment of Transcutaneous Oxygen Tension and Oxygen Challenge Test in Adult Intensive Care Patients
Status: UNKNOWN
Status Verified Date: 2010-08
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: ICUPtO2OCT
Brief Summary: The lack of subcutaneous partial pressure of oxygen (PO2) rise in response to high fraction of inspired oxygen (FiO2), called the "oxygen challenge test (OCT)", was associated with higher morbidity and mortality in human subjects. Patients had negative O2 challenge test results, indicating that flow-dependent O2 consumption might have been present. Recent reports using the noninvasive transcutaneous PO2 (PtO2) and transcutaneous partial pressure of carbon dioxide probes have observed a relationship between low oxygen challenge test values to mortality and organ failure. The OCT values provides an accessible noninvasive method of detecting early shock.

To date,these studies of OCT in the ICU patients are rarely. No one has quantified OCT to CI, DO2I、ScvO2.

This study explored:

1. relationship between patient factors, hemodynamic variables, PtO2, and OCT to mortality;
2. relationship between PtO2 index, tissue oxygen index, oxygen Challenge index to CI, DO2, ScvO2.
Detailed Description: PtO2 index = PtO2/PaO2;tissue oxygen index=PtO2/FiO2;

5min OCT value = challenged 5minPtO2 - PtO2baseline;

10min OCT value= challenged 10minPtO2- PtO2baseline;

oxygen challenge index = (10minPtO2- PtO2baseline)/(10minPaO2-PaO2baseline)

Study Oversight

Has Oversight DMC: True
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?: