Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-05-13 @ 6:11 AM
Study NCT ID:
NCT02946502
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2016-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Handgrip Strength Value in Predicting Mechanical Ventilation Weaning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-17'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-01', 'studyFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'extubation outcome according to handgrip strength value', 'timeFrame': '7 days', 'description': 'Each mechanical ventilation weaning trial'}], 'secondaryOutcomes': [{'measure': 'Association between handgrip strength and difficulty of weaning according to guidelines', 'timeFrame': '7 days', 'description': 'Each mechanical ventilation weaning trial'}, {'measure': 'Association between handgrip strength and cough strength as assessed through peak expiratory flow evaluated with a portable spirometer', 'timeFrame': '7 days', 'description': 'Each mechanical ventilation weaning trial'}, {'measure': 'Association between handgrip strength and maximal inspiratory strength during a brief inspiratory valve occlusion on the ventilator', 'timeFrame': '7 days', 'description': 'Each mechanical ventilation weaning trial'}, {'measure': 'Association between handgrip strength and peripheral muscular strength evaluated by the Medical Research Council score', 'timeFrame': '7 days', 'description': 'Each mechanical ventilation weaning trial'}, {'measure': 'Association between handgrip strength and the peripheral muscular strength evaluated by the Medical Research Council score. (Global score and its components)', 'timeFrame': '7 days', 'description': 'Each mechanical ventilation weaning trial'}, {'measure': 'Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital length of stay', 'timeFrame': '18 months'}, {'measure': 'Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital survival', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ventilator Weaning', 'Hand Strength', 'Respiration']}, 'referencesModule': {'references': [{'pmid': '34601639', 'type': 'DERIVED', 'citation': 'Cottereau G, Messika J, Megarbane B, Guerin L, da Silva D, Bornstain C, Santos M, Ricard JD, Sztrymf B. Handgrip strength to predict extubation outcome: a prospective multicenter trial. Ann Intensive Care. 2021 Oct 2;11(1):144. doi: 10.1186/s13613-021-00932-3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the association between ICU acquired weakness as evaluated by dominant handheld dynamometry (handgrip) and the mechanical ventilation weaning outcome', 'detailedDescription': 'Previous studies have evidenced that Intensive Care Unit acquired peripheral muscle weakness may lead to delayed mechanical ventilation weaning (i.e difficult or prolonged weaning according to guidelines). Nevertheless, no study has ever tested the association between handgrip strength and extubation outcome. The investigators have generated the hypothesis that ICU acquired weakness, as tested by handgrip strength might be associated with extubation outcome. The investigators have planned to include 240 patients. Handgrip strength will be monitored, along with a full muscular assessment through Medical Research Council score by the attending physiotherapist. Physicians in charge of the patients will be blinded to these values and the weaning protocol will continue according to guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients\n* under mechanical ventilation for at least 48 hours\n* meeting readiness to wean criteria according to international guidelines\n* with social security\n* informed consent given by the patient or a proxy\n\nExclusion Criteria:\n\n* baseline pre existing rheumatologic or neurologic condition preventing the patient to use the tested device\n* confusion (as assessed by Confusion Assessment Method for the Intensive Care Unit )\n* Patients whose extubation is a terminal extubation, or with prior decision not to resort a reintubation in case of post-extubation respiratory distress.\n* known pregnancy\n* Inability to deliver clear patient information (language barrier without an interpreter, for example)\n* Participation in another intervention research'}, 'identificationModule': {'nctId': 'NCT02946502', 'acronym': 'GRIPWEAN', 'briefTitle': 'Handgrip Strength Value in Predicting Mechanical Ventilation Weaning', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prognostic Value of Dominant Hand Held Dynamometry in Mechanical Ventilation Weaning: a Prospective, Multicenter Study', 'orgStudyIdInfo': {'id': 'P150948'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Handheld dynamometry (handgrip strength)', 'description': 'All included patients will have a blinded evaluation of handgrip strength before weaning process.', 'interventionNames': ['Procedure: Handheld dynamometry (handgrip strength)']}], 'interventions': [{'name': 'Handheld dynamometry (handgrip strength)', 'type': 'PROCEDURE', 'description': 'Patients will perform handgrip strength dynamometry through holding the device in their dominant hand with the maximum strength, with standardized arm and body positions, as well as incentives', 'armGroupLabels': ['Handheld dynamometry (handgrip strength)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clamart', 'country': 'France', 'facility': 'Benjamin Sztrymf', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}