Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT00419458
Status:
COMPLETED
Last Update Posted:
2009-11-09
First Post:
2007-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inspiratory Muscle Training in Ventilator Dependent Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-06', 'studyFirstSubmitDate': '2007-01-04', 'studyFirstSubmitQcDate': '2007-01-04', 'lastUpdatePostDateStruct': {'date': '2009-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ventilator dependent status'}], 'secondaryOutcomes': [{'measure': 'breathing patterns during failed and passed unsupported breathing trials'}, {'measure': 'maximal inspiratory pressure'}]}, 'conditionsModule': {'keywords': ['ventilator weaning', 'weaning', 'respiratory failure', 'inspiratory muscle strength training'], 'conditions': ['Failure to Wean', 'Respiratory Failure', 'Ventilator Dependent']}, 'referencesModule': {'references': [{'pmid': '16569266', 'type': 'BACKGROUND', 'citation': 'Ozcan MS, Bonett SW, Martin AD, Gabrielli A, Layon AJ, Banner MJ. Abnormally increased power of breathing as a complication of closed endotracheal suction catheter systems. Respir Care. 2006 Apr;51(4):423-5. No abstract available.'}, {'pmid': '21385346', 'type': 'DERIVED', 'citation': 'Martin AD, Smith BK, Davenport PD, Harman E, Gonzalez-Rothi RJ, Baz M, Layon AJ, Banner MJ, Caruso LJ, Deoghare H, Huang TT, Gabrielli A. Inspiratory muscle strength training improves weaning outcome in failure to wean patients: a randomized trial. Crit Care. 2011;15(2):R84. doi: 10.1186/cc10081. Epub 2011 Mar 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if inspiratory muscle strength training will increase the proportion of ventilator dependent patients weaned versus Sham treated patients.', 'detailedDescription': 'The inspiratory muscle strength training consists of 4 sets of 6-10 breaths through a threshold inspiratory muscle strength training device, 5 days per week. The inspiratory muscle training is conducted at the highest pressure setting tolerated by the patients. The Sham groups uses an inspiratory muscle trainer that does not increase inspiratory muscle strength. Both the treated and Sham groups participate in progressively lengthening periods of breathing without ventilator as tolerated. Patients are considered weaned when they can breathe for 72 consecutive hours without any ventilator support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Failure to wean patients in the medial, surgical and intermediate respiratory care units at Shands Hospital\n* medically stable\n* able to initiate spontaneous breaths\n* able to provide informed consent\n* able to follow simple instructions\n\nExclusion Criteria:\n\n* life expectancy \\< 12 months due to malignancy\n* damaged phrenic nerves\n* neuromuscular diseases\n* heart or lung transplant'}, 'identificationModule': {'nctId': 'NCT00419458', 'briefTitle': 'Inspiratory Muscle Training in Ventilator Dependent Patients', 'organization': {'class': 'NIH', 'fullName': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, 'officialTitle': 'Respiratory Muscle Training in Ventilator Dependent Patients', 'orgStudyIdInfo': {'id': 'NICHD 5R01HD42705'}}, 'armsInterventionsModule': {'interventions': [{'name': 'inspiratory muscle strength training', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Deprtment of Physical Therapy/Shands Hospital at the University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Anatole D Martin, Ph D, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}, {'name': 'Andrea Gabrielli, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Florida'}, {'name': 'Paul Davenport, Ph D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Florida'}, {'name': 'Joseph Layon, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Florida'}, {'name': 'Maher Baz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Florida'}, {'name': 'Lawrence Caruso, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Florida'}, {'name': 'Ricardo Gonzalez-Rothi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Florida'}, {'name': 'Elosie Harman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Florida'}, {'name': 'Micheal Banner, Ph D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}}}}