Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-03 @ 5:45 PM
Study NCT ID:
NCT02015858
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2013-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-28', 'studyFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2013-12-13', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain monitor evaluation of pain', 'timeFrame': '1 hour', 'description': 'Comparison between Pain monitor index and auto-evaluation of pain (numerical scale from 0 -no pain- to 10 - maximal pain)'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '1 hour', 'description': 'Evolution of Pain monitor index and of auto-evaluation of pain (numerical scale from 0 -no pain- to 10 - maximal pain) during the chest tube withdrawal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chest Pain']}, 'descriptionModule': {'briefSummary': 'Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the measurement of skin conductance.\n\nWithdrawal of chest tube can be painful and the purpose of the study was to compare auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lung surgical patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing removal of a chest tube after lung surgery,\n* patients able to indicate the pain score.\n\nExclusion Criteria:\n\n* pregnancy, lactation ,\n* insulin-dependent diabetes with dysautonomia,\n* central or peripheral neurological disease, agitation,\n* inability to understand the protocol,\n* inability to use the Pain Monitor: skin abnormalities at the site of measurement, pacemaker or implantable defibrillator, condition affecting the sympathetic nervous system, tremor of the extremities,\n* contra-indication to oral morphine ,\n* respiratory failure, severe hepatic insufficiency, intracranial hypertension, epilepsy associations\n* recent administration of neostigmine or of atropine.'}, 'identificationModule': {'nctId': 'NCT02015858', 'acronym': 'Pain Drain', 'briefTitle': 'Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor in Patients With or Without Epidural Anesthesia', 'orgStudyIdInfo': {'id': '2013/22'}, 'secondaryIdInfos': [{'id': '2013-A00612-43', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epidural analgesia', 'description': 'Postoperative patients with epidural analgesia', 'interventionNames': ['Procedure: Chest drain withdrawal', 'Device: Pain Monitor']}, {'label': 'Oral analgesics', 'description': 'Postoperative patients with oral analgesics', 'interventionNames': ['Procedure: Chest drain withdrawal', 'Device: Pain Monitor']}], 'interventions': [{'name': 'Chest drain withdrawal', 'type': 'PROCEDURE', 'armGroupLabels': ['Epidural analgesia', 'Oral analgesics']}, {'name': 'Pain Monitor', 'type': 'DEVICE', 'otherNames': ['Measurement of Pain Monitor index'], 'armGroupLabels': ['Epidural analgesia', 'Oral analgesics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital 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'}}}}