Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-29 @ 6:29 PM
Study NCT ID:
NCT01169506
Status:
COMPLETED
Last Update Posted:
2010-08-09
First Post:
2010-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sublingual Tonometry to Assess Tissue Perfusion in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-06', 'studyFirstSubmitDate': '2010-07-23', 'studyFirstSubmitQcDate': '2010-07-23', 'lastUpdatePostDateStruct': {'date': '2010-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sublingual tonometric PCO2 - arterial PCO2', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'sublingual tonometric PCO2 - PETCO2', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['blood gas analysis', 'ventilatory insufficiency'], 'conditions': ['COPD', 'Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '16805933', 'type': 'BACKGROUND', 'citation': 'Boda D, Kaszaki J, Talosi G. A new simple tool for tonometric determination of the PCO2 in the gastrointestinal tract: in vitro and in vivo validation studies. Eur J Anaesthesiol. 2006 Aug;23(8):680-5. doi: 10.1017/S026502150600055X.'}]}, 'descriptionModule': {'briefSummary': 'Sublingual positioning of a silicon capillary system is applied. After 15 min, while the individual is in resting position with closed mouth and normal tidal breathing through the nose is performed, the silicon capillary system is connected to a capnometer and CO2 tension is measured.\n\nThe investigators hypothesis is that this setup offers a non-invasive assessment of ventilatory efficiency with similar accuracy as arterial PCO2.', 'detailedDescription': 'We have developed a new silicon capillary system for sublingual monitoring of CO2 tension in order to assess tissue perfusion. This set up is non-invasive, cheaper than previous tonometry devices and easier to apply in clinical routine. We have recruited patients with stable COPD and healthy individuals.\n\nSublingual tonometry results were evaluated after 15 min of tidal breathing with a capnometer for CO2 tension. Corresponding end tidal CO2 (PETCO2)and arterial blood gas values (pH, PaCO2, PaCO2) were also investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients with stable disease\n\nExclusion Criteria:\n\n* acute exacerbation of COPD'}, 'identificationModule': {'nctId': 'NCT01169506', 'acronym': 'subton', 'briefTitle': 'Sublingual Tonometry to Assess Tissue Perfusion in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'Szeged University'}, 'officialTitle': 'A New Method of Sublingual Tonometry to Assess Tissue Perfusion in Patients With COPD and Healthy Individuals', 'orgStudyIdInfo': {'id': 'nagymaci54'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COPD patients and healthy individuals', 'interventionNames': ['Device: sublingual silicon capillary']}], 'interventions': [{'name': 'sublingual silicon capillary', 'type': 'DEVICE', 'otherNames': ['sublingual tonometry, tissue perfusion, ventilation'], 'description': 'Stable patients with COPD and healthy individuals were asked to open their mouth and a small butterfly silicon capillary was placed sublingually. After 15 minutes, while the mouth was closed completely and nose breathing was performed, the capillary system was connected to a capnometer and sublingual tonometric PCO2 was measured. At the same time, PETCO2 was also measured and arterial blood was drawn for pH, PO2 and PCO2 analysis', 'armGroupLabels': ['COPD patients and healthy individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6772', 'city': 'Deszk', 'country': 'Hungary', 'facility': 'Department of Pulmonology, Albert Szent-Györgyi Clinical Center, University of Szeged', 'geoPoint': {'lat': 46.21802, 'lon': 20.24322}}], 'overallOfficials': [{'name': 'Attila Somfay, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pulmonology, University of Szeged, Hungary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Szeged University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Attila Somfay, MD, PhD', 'oldOrganization': 'Department of Pulmonology, University of Szeged, Hngary'}}}}