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Assessment of Transcutaneous Oxygen Tension/Oxygen Challenge Test in Intensive Care Unit (ICU) Patients (ICUPtO2OCT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Peking Union Medical College Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01174966
First received: August 2, 2010
Last updated: August 3, 2010
Last verified: August 2010
History of Changes
  Purpose

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.

Condition
Sepsis
Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Transcutaneous Oxygen Tension and Oxygen Challenge Test in Adult Intensive Care Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • ICU mortality [ Time Frame: 28 day after enrollmented ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hospital mortality [ Time Frame: 28 day after enrollmented ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Survivor Nonsurvivor

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)

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The subjects were sequentially admitted to the Department of Critical Care department of Peking Union Medical College Hospital from sept. of 2009 till the end of this study.

Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Requiring a artery catheters, and pulmonary artery catheters or PiCCO-plus or central venous catheters
  • FiO2<80% and SpO2>92%
  • Consent informed

Exclusion Criteria:

  • Not expected to live
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174966

Contacts
Contact: dawei liu, MD 010-65296091 dwliu98@yahoo.com
Contact: huaiwu he 010-65296094 tjmuhhw@hotmail.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: dawei liu, MD     010-65296091     dwliu98@yahoo.com    
Contact: huaiwu he     010-65296094     tjmuhhw@hotmail.com    
Sub-Investigator: huaiwu he            
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: dawei liu, MD Peking Union Medical College Hospital
  More Information

Publications:

Responsible Party: Da wei liu, MD , Professor , Director of Department of Critical Care Medicine, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01174966     History of Changes
Other Study ID Numbers: PUMCH-ICU-LDW-OCT
Study First Received: August 2, 2010
Last Updated: August 3, 2010
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
oxygen challenge test
shock
mortality
Oxygen Delivery Index
cardiac output index

Additional relevant MeSH terms:
Sepsis
Shock
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013