Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-26 @ 8:12 PM
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-03', 'studyFirstSubmitDate': '2010-08-02', 'studyFirstSubmitQcDate': '2010-08-03', 'lastUpdatePostDateStruct': {'date': '2010-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU mortality', 'timeFrame': '28 day after enrollmented'}], 'secondaryOutcomes': [{'measure': 'hospital mortality', 'timeFrame': '28 day after enrollmented'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['oxygen challenge test', 'shock', 'mortality', 'Oxygen Delivery Index', 'cardiac output index'], 'conditions': ['Sepsis', 'Shock']}, 'referencesModule': {'references': [{'pmid': '17047514', 'type': 'BACKGROUND', '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.'}, {'pmid': '17505300', 'type': 'BACKGROUND', '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.'}, {'pmid': '3580798', 'type': 'BACKGROUND', '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.'}, {'pmid': '610773', 'type': 'BACKGROUND', '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.'}, {'pmid': '4057292', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nTo date,these studies of OCT in the ICU patients are rarely. No one has quantified OCT to CI, DO2I、ScvO2.\n\nThis study explored:\n\n1. relationship between patient factors, hemodynamic variables, PtO2, and OCT to mortality;\n2. relationship between PtO2 index, tissue oxygen index, oxygen Challenge index to CI, DO2, ScvO2.', 'detailedDescription': 'PtO2 index = PtO2/PaO2；tissue oxygen index=PtO2/FiO2；\n\n5min OCT value = challenged 5minPtO2 - PtO2baseline；\n\n10min OCT value= challenged 10minPtO2- PtO2baseline；\n\noxygen challenge index = （10minPtO2- PtO2baseline）/(10minPaO2-PaO2baseline)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Requiring a artery catheters, and pulmonary artery catheters or PiCCO-plus or central venous catheters\n* FiO2\\<80% and SpO2\\>92%\n* Consent informed\n\nExclusion Criteria:\n\n* Not expected to live'}, 'identificationModule': {'nctId': 'NCT01174966', 'acronym': 'ICUPtO2OCT', 'briefTitle': 'Assessment of Transcutaneous Oxygen Tension/Oxygen Challenge Test in Intensive Care Unit (ICU) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Assessment of Transcutaneous Oxygen Tension and Oxygen Challenge Test in Adult Intensive Care Patients', 'orgStudyIdInfo': {'id': 'PUMCH-ICU-LDW-OCT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survivor Nonsurvivor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'dawei liu, MD', 'role': 'CONTACT', 'email': 'dwliu98@yahoo.com', 'phone': '010-65296091'}, {'name': 'huaiwu he', 'role': 'CONTACT', 'email': 'tjmuhhw@hotmail.com', 'phone': '010-65296094'}, {'name': 'huaiwu he', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'dawei liu, MD', 'role': 'CONTACT', 'email': 'dwliu98@yahoo.com', 'phone': '010-65296091'}, {'name': 'huaiwu he', 'role': 'CONTACT', 'email': 'tjmuhhw@hotmail.com', 'phone': '010-65296094'}], 'overallOfficials': [{'name': 'dawei liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Da wei liu, MD , Professor , Director of Department of Critical Care Medicine', 'oldOrganization': 'Peking Union Medical College Hospital'}}}}