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

Sepsis Clinical Trial

— ICUPtO2OCT  

Official title:

Assessment of Transcutaneous Oxygen Tension and Oxygen Challenge Test in Adult Intensive Care Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01174966
• Other study ID #: PUMCH-ICU-LDW-OCT
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2010
• Last updated: August 3, 2010
• Start date: September 2009
• Est. completion date: October 2010

Study information

• Verified date: August 2010
• Source: Peking Union Medical College Hospital
• Contact: dawei liu, MD
• Phone: 010-65296091
• Email: dwliu98[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Shock

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU mortality		28 day after enrollmented	Yes
Secondary	hospital mortality		28 day after enrollmented	Yes