Clinical trial NCT01174966: Assessment of Transcutaneous Oxygen Tension/Oxygen Challenge Test in Intensive Care Unit (ICU) Patients
Official title: Assessment of Transcutaneous Oxygen Tension and Oxygen Challenge Test in Adult Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Shock
Keywords: oxygen challenge test
shock
mortality
Oxygen Delivery Index
cardiac output index
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2010-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

Eligibility 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

Primary outcomes:
measure: ICU mortality
timeFrame: 28 day after enrollmented
Secondary outcomes:
measure: hospital mortality
timeFrame: 28 day after enrollmented
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: dawei liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu M, Morita SY, Daniel SR, Chapital A, Waxman K, Severino R. Transcutaneous pressure of oxygen: a noninvasive and early detector of peripheral shock and outcome. Shock. 2006 Nov;26(5):450-6. doi: 10.1097/01.shk.0000228798.18174.6a.
citation: Yu M, Chapital A, Ho HC, Wang J, Takanishi D Jr. A prospective randomized trial comparing oxygen delivery versus transcutaneous pressure of oxygen values as resuscitative goals. Shock. 2007 Jun;27(6):615-22. doi: 10.1097/shk.0b013e31802f0295.
citation: Jonsson K, Jensen JA, Goodson WH 3rd, West JM, Hunt TK. Assessment of perfusion in postoperative patients using tissue oxygen measurements. Br J Surg. 1987 Apr;74(4):263-7. doi: 10.1002/bjs.1800740413.
citation: Goeckenjan G, Strasser K. Relation of transcutaneous to arterial pO2 in hypoxaemia, normoxaemia and hyperoxaemia. Investigations in adults with normal circulation and in patients with circulatory insufficiency. Biotelemetry. 1977;4(2):77-87.
citation: Reed RL 2nd, Maier RV, Landicho D, Kenny MA, Carrico CJ. Correlation of hemodynamic variables with transcutaneous PO2 measurements in critically ill adult patients. J Trauma. 1985 Nov;25(11):1045-53.