Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-09 @ 6:53 AM
Study NCT ID:
NCT01255033
Status:
COMPLETED
Last Update Posted:
2016-09-23
First Post:
2010-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxygen Peripheral Saturations and Lung Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-22', 'studyFirstSubmitDate': '2010-12-05', 'studyFirstSubmitQcDate': '2010-12-05', 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Desaturation during surgery and early postoperative recovery whatever the device.', 'timeFrame': '6 hours postoperative', 'description': 'Number of episodes'}], 'secondaryOutcomes': [{'measure': 'Chronology between devices in case of desaturation', 'timeFrame': '6 hours post operative'}, {'measure': 'Quality of signal', 'timeFrame': '6 hours postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['perioperative surgery', 'regional oxygenation', 'hypoxemia', 'brain hypoxemia', 'spectroscopy, near-infrared'], 'conditions': ['Pulmonary Surgical Procedures', 'Recovery Period']}, 'referencesModule': {'references': [{'pmid': '19625198', 'type': 'BACKGROUND', 'citation': 'Manfredini F, Malagoni AM, Felisatti M, Mandini S, Mascoli F, Manfredini R, Basaglia N, Zamboni P. A dynamic objective evaluation of peripheral arterial disease by near-infrared spectroscopy. Eur J Vasc Endovasc Surg. 2009 Oct;38(4):441-8. doi: 10.1016/j.ejvs.2009.06.011. Epub 2009 Jul 21.'}, {'pmid': '19183952', 'type': 'BACKGROUND', 'citation': 'Mesquida J, Masip J, Gili G, Artigas A, Baigorri F. Thenar oxygen saturation measured by near infrared spectroscopy as a noninvasive predictor of low central venous oxygen saturation in septic patients. Intensive Care Med. 2009 Jun;35(6):1106-9. doi: 10.1007/s00134-009-1410-y. Epub 2009 Jan 29.'}, {'pmid': '19918024', 'type': 'RESULT', 'citation': 'Kazan R, Bracco D, Hemmerling TM. Reduced cerebral oxygen saturation measured by absolute cerebral oximetry during thoracic surgery correlates with postoperative complications. Br J Anaesth. 2009 Dec;103(6):811-6. doi: 10.1093/bja/aep309.'}, {'pmid': '19059925', 'type': 'RESULT', 'citation': 'Hemmerling TM, Kazan R, Bracco D. Inter-hemispheric cerebral oxygen saturation differences during thoracic surgery in lateral head positioning. Br J Anaesth. 2009 Jan;102(1):141-2. doi: 10.1093/bja/aen336. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the ability of two peripheral and non invasive devices to detect hypoxic events during one-lung ventilation and during the early postoperative period. One device measures regional cerebral oxygenation and the other muscular oxygenation. These two devices are compared to non invasive arterial saturation (SpO2), which is the gold standard.', 'detailedDescription': 'Lung surgery is often complicated by hypoxic evants :\n\n* during one-lung ventilation which leads to changes about ratio in ventilated and perfused lung areas. This blood flow redistribution promotes shunt with a decreased arterial oxygenation and possible hypoxemia.\n* during the postoperative period.\n\nCommon measure of arterial saturation through SpO2 may miss a great number of hypoxic events with regional impact because a significant decrease in SpO2 occurs for an arterial pressure in oxygen below 60 mmHg. Currently, cerebral and somatic saturation can be monitored non-invasively and continuously via optical sensors applied to the right and left forehead and to the thenar eminence. These devices may help clinicians in the detection of such hypoxemic events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients submitted for scheduled lung surgery requiring one-lung ventilation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled lung surgery requiring one-lung ventilation\n* informed consent\n\nExclusion Criteria:\n\n* Pregnant woman\n* Neurologic or psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT01255033', 'briefTitle': 'Oxygen Peripheral Saturations and Lung Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Evaluation of the Continuous Measurement of Tissular (StO2) and Cerebral (ScO2) Oxygenation During Lung Surgery and During the 6 First Postoperative Hours (Prospective Monocentric Study).', 'orgStudyIdInfo': {'id': '2010/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary surgical patients', 'description': 'Patients submitted for scheduled lung surgery requiring one-lung ventilation', 'interventionNames': ['Device: Monitoring of tissular oxygenation']}], 'interventions': [{'name': 'Monitoring of tissular oxygenation', 'type': 'DEVICE', 'description': 'Equanox: cerebral oxygenation by spectroscopy, near-infrared through forehead and noninvasive devices\n\nInspectra: tissular oxygenation by spectroscopy, near-infrared through thenar and noninvasive device', 'armGroupLabels': ['Pulmonary surgical patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92151', 'city': 'Suresnes', 'state': 'France', 'country': 'France', 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Marc Fischler', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}