Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-02 @ 10:15 AM
Study NCT ID:
NCT05396066
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory and Quadriceps Muscle Fatigability After an ICU Acquired Weakness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2022-03-10', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Respiratory muscle strength', 'timeFrame': 'One day', 'description': 'Respiratory muscle strength will be assessed by Maximal Inspiratory pressure in centimeter of water. The measure will carry out by an electronical manometer'}, {'measure': 'Change in quadriceps muscle strength', 'timeFrame': 'One day', 'description': 'Quadriceps muscle strength will be assessed by Maximal Voluntary contraction of the quadriceps in Newton. The measure will carry out by an electronical dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ICU acquired weakness', 'Muscle strength', 'fatigability', 'respiratory muscle', 'Quadriceps muscle'], 'conditions': ['ICU Acquired Weakness']}, 'referencesModule': {'references': [{'pmid': '40114068', 'type': 'DERIVED', 'citation': "Machefert M, Prieur G, Aubry S, Combret Y, Medrinal C. Respiratory and limb muscles' ability to repeatedly generate maximal isometric strength in patients with intensive care unit-acquired weakness: an observational study. BMC Anesthesiol. 2025 Mar 20;25(1):134. doi: 10.1186/s12871-025-03008-y."}]}, 'descriptionModule': {'briefSummary': 'Muscle dysfunction can be lead to poor outcomes moreover ICU muscle weakness recovery are not correctly described.\n\nThe investigators aimed to assess the ability for quadriceps or respiratory muscles to repeat an effort at a maximal loading.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients weaned from mechanical ventilation and developping ICU muscle weakness diagnosed by a maximal inspiratory pressure and a MRC score', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanically ventilated at least at 24 Hours\n* Maximal inspiratory pressure \\< 30 centimeter of water\n* MRC score \\< 48/60\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Patients with neurological pathology or pre existing neuromuscular dysfunction\n* Patient unable to walk 50 meters before ICU admission\n* Patient with a thoracic or abdominal surgery\n* Inability to carry out maximal voluntary contraction'}, 'identificationModule': {'nctId': 'NCT05396066', 'briefTitle': 'Respiratory and Quadriceps Muscle Fatigability After an ICU Acquired Weakness', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier du Havre'}, 'officialTitle': 'Comparison Between Respiratory and Quadriceps Muscle Fatigability During a Maximal Loading for ICU Weakness Patients', 'orgStudyIdInfo': {'id': '2021-A02816-35'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Muscle evaluation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Repeated maximal voluntary contraction'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76290', 'city': 'Montivilliers', 'state': 'Groupe Hospitalier Du Havre', 'country': 'France', 'facility': 'Groupe Hospitalier du Havre', 'geoPoint': {'lat': 49.54518, 'lon': 0.18769}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier du Havre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}