Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-13 @ 11:34 AM
Study NCT ID:
NCT01931228
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2013-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical Insufflation-Exsufflation in Preventing Post Extubation Respiratory Failure in Patient With Critical Care Neuromyopathy
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2013-08-22', 'studyFirstSubmitQcDate': '2013-08-22', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of respiratory failure after extubation', 'timeFrame': '48h post extubation (48h after inclusion)'}], 'secondaryOutcomes': [{'measure': 'the increase in peak cough flow', 'timeFrame': 'End of intensive care or day 28 after inclusion'}, {'measure': 'the incidence of reintubation', 'timeFrame': 'End of intensive care or day 28 after inclusion'}, {'measure': 'the average time of hospitalization in the intensive care unit', 'timeFrame': 'End of intensive care or day 28 after inclusion'}, {'measure': 'the incidence of nasotracheal suction', 'timeFrame': 'End of intensive care or day 28 after inclusion'}, {'measure': 'the number of additional physiotherapy sessions', 'timeFrame': 'End of intensive care or day 28 after inclusion'}, {'measure': 'the ICU mortality or 28-day survival', 'timeFrame': '28 days after inclusion'}, {'measure': '90 days survival', 'timeFrame': '90 days after inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intensive care unit', 'acute respiratory insufficiency', 'Respiratory failure', 'Mechanical Insufflation-Exsufflation'], 'conditions': ['Acute Respiratory Insufficiency', 'Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '37712806', 'type': 'DERIVED', 'citation': 'Wibart P, Reginault T, Garcia-Fontan M, Barbrel B, Bader C, Benard A, Parreira VF, Gonzalez-Anton D, Bui NH, Gruson D, Hilbert G, Martinez-Alejos R, Vargas F. Effects of mechanical in-exsufflation in preventing postextubation acute respiratory failure in intensive care acquired weakness patients: a randomized controlled trial. Crit Care Sci. 2023 Apr-Jun;35(2):168-176. doi: 10.5935/2965-2774.20230410-en.'}]}, 'descriptionModule': {'briefSummary': 'Respiratory failure after extubation is a relevant consequence of poor airway clearance due to respiratory muscle weakness and respiratory failure after extubation and reintubation is associated with increased morbidity and mortality.\n\nthe study will evaluate the contribution of Mechanical Insufflation-Exsufflation (MI-E) in Preventing Respiratory Failure After Extubation as compared manually assisted coughing', 'detailedDescription': 'Critical Care Neuromyopathy (CCN) occur in 25% of patient in Intensive Care Unit (ICU). Respiratory failure after extubation is a relevant consequences of poor airway clearance due to respiratory muscle weakness. Respiratory failure is a major cause for reintubation which increase severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. Currently, respiratory physiotherapy includes, manual expiration assist often associated with nasotracheal aspiration. Despite of this care, respiratory failure occur in 30% of patients within 48 after planned extubation. MI-E has been evaluated for neuromuscular disease patient, and increase peak cough flow and the airway clearance. So the beneficials effects of MI-E should be confirmed in a trial in this specific population.\n\nWe planned to conduct a study evaluating the efficacy of MI-E in the prevention of extubation failure and mortality in these patients. If no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to MI-E group or control group. The clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the ICU or 28-day survival,90-day survival, ICU length of stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Male or female patient aged ≥ 18 years.\n* Patient admitted in participant ICU.\n* Patient intubated for 48 hours at least.\n* Patient presenting an ICU acquired neuromuscular disorders.\n\nExclusion criteria:\n\n* Respiratory or haemodynamic instability.\n* Patient having a contraindication to use face mask (Recent facial surgery, severe craniofacial trauma,…) gastroesophageal surgery.\n* Severe ventricular rhythm disorders.\n* Patient with tracheotomy.\n* Uncontrollable vomiting.\n* Severe sepsis.\n* Upper airway disorders.\n* Upper gastrointestinal bleeding.\n* Any decision to limit therapeutic effort in the ICU.\n* Patient with limit therapeutic effort in the ICU with unsuccessful spontaneous respiratory trial.'}, 'identificationModule': {'nctId': 'NCT01931228', 'acronym': 'NEUROMIE', 'briefTitle': 'Mechanical Insufflation-Exsufflation in Preventing Post Extubation Respiratory Failure in Patient With Critical Care Neuromyopathy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Contribution of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure Post Extubation in Patient With Critical Care Neuromyopathy', 'orgStudyIdInfo': {'id': 'CHUBX 2011/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MI-E plus manually assisted coughing', 'interventionNames': ['Procedure: MI-E plus manually assisted coughing']}, {'type': 'EXPERIMENTAL', 'label': 'Manually assisted coughing only', 'interventionNames': ['Procedure: manually assisted coughing']}], 'interventions': [{'name': 'MI-E plus manually assisted coughing', 'type': 'PROCEDURE', 'description': 'MI-E plus manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session.', 'armGroupLabels': ['MI-E plus manually assisted coughing']}, {'name': 'manually assisted coughing', 'type': 'PROCEDURE', 'description': 'Manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session.', 'armGroupLabels': ['Manually assisted coughing only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Philippe WIBART, Physical therapist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'Antoine BENARD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}