Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT01304056
Status:
WITHDRAWN
Last Update Posted:
2013-10-09
First Post:
2011-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How to Study Ventilatory Physiology With the Help of Surface Electromyography (EMG) Recordings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Finland']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Administrative reasons', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-08', 'studyFirstSubmitDate': '2011-02-24', 'studyFirstSubmitQcDate': '2011-02-24', 'lastUpdatePostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ventilatory physiology'], 'conditions': ['Ventilatory Physiology']}, 'descriptionModule': {'briefSummary': 'Respiratory muscles seem to be activating differently in critically ill patients than in healthy persons. Needle electrodes would provide artefact-free signal information about muscle activation. However, needle recordings are an invasive technique which limits its feasibility in clinical setting. Intention of this study is to investigate if surface electromyography could be used to measure recruitment patterns of ventilatory muscles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult population \\> 18 years of age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years of age\n\nExclusion Criteria:\n\n* brain death of injury\n* high spinal cord injury\n* severe ARDS (static compliance below 40, PFI below 150)'}, 'identificationModule': {'nctId': 'NCT01304056', 'briefTitle': 'How to Study Ventilatory Physiology With the Help of Surface Electromyography (EMG) Recordings', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'orgStudyIdInfo': {'id': 'R08175'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill patients', 'description': 'Patients that are treated in intensive care unit and given ventilatory therapy.', 'interventionNames': ['Device: Ventilatory therapy']}, {'label': 'Interventional volunteer group', 'description': 'Healthy volunteers'}], 'interventions': [{'name': 'Ventilatory therapy', 'type': 'DEVICE', 'armGroupLabels': ['Critically ill patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jyrki Tenhunen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Critical Care Medicine Research Group, Tampere University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}