NCT01174966

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. 1.relationship between patient factors, hemodynamic variables, PtO2, and OCT to mortality;
  2. 2.relationship between PtO2 index, tissue oxygen index, oxygen Challenge index to CI, DO2, ScvO2.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

August 4, 2010

Status Verified

August 1, 2010

Enrollment Period

1.1 years

First QC Date

August 2, 2010

Last Update Submit

August 3, 2010

Conditions

SepsisShock

Keywords

oxygen challenge testshockmortalityOxygen Delivery Indexcardiac output index

Outcome Measures

Primary Outcomes (1)

  • ICU mortality

    28 day after enrollmented

Secondary Outcomes (1)

  • hospital mortality

    28 day after enrollmented

Study Arms (1)

Survivor Nonsurvivor

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Not expected to live

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 17047514BACKGROUND

  • 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.

    PMID: 17505300BACKGROUND

  • 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.

    PMID: 3580798BACKGROUND

  • 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.

    PMID: 610773BACKGROUND

  • 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.

    PMID: 4057292BACKGROUND

MeSH Terms

Conditions

SepsisShock

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • dawei liu, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

dawei liu, MD

CONTACT

010-65296091dwliu98@yahoo.com

huaiwu he

CONTACT

010-65296094tjmuhhw@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2010

First Posted

August 4, 2010

Study Start

September 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

August 4, 2010

Record last verified: 2010-08

Locations

CN(1)