Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT07143695
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parasternal Intercostal Muscle Thickening as an Additive Weaning Criterion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of reintubation', 'timeFrame': 'Within 72 hours after extubation', 'description': 'need for reintubation'}], 'secondaryOutcomes': [{'measure': 'Incidence of weaning failure', 'timeFrame': 'within 72 hours post-extubation', 'description': 'failed spontaneous breathing trial or reintubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weaning', 're-intubation', 'mechanical ventilation'], 'conditions': ['Critically Ill']}, 'referencesModule': {'references': [{'pmid': '35487407', 'type': 'BACKGROUND', 'citation': 'Helmy MA, Hasanin A, Milad LM, Mostafa M, Fathy S. Parasternal intercostal muscle thickening as a predictor of non-invasive ventilation failure in patients with COVID-19. Anaesth Crit Care Pain Med. 2022 Jun;41(3):101063. doi: 10.1016/j.accpm.2022.101063. Epub 2022 Apr 26. No abstract available.'}, {'pmid': '36961635', 'type': 'BACKGROUND', 'citation': 'Helmy MA, Milad LM, Hasanin AM, Mostafa M, Mannaa AH, Youssef MM, Abdelaziz M, Alkonaiesy R, Elshal MM, Hosny O. Parasternal intercostal thickening at hospital admission: a promising indicator for mechanical ventilation risk in subjects with severe COVID-19. J Clin Monit Comput. 2023 Oct;37(5):1287-1293. doi: 10.1007/s10877-023-00989-4. Epub 2023 Mar 24.'}, {'pmid': '39174907', 'type': 'BACKGROUND', 'citation': 'Helmy MA, Hasanin A, Milad LM, Mostafa M, Hamimy WI, Muhareb RS, Raafat H. Ability of parasternal intercostal muscle thickening fraction to predict reintubation in surgical patients with sepsis. BMC Anesthesiol. 2024 Aug 22;24(1):294. doi: 10.1186/s12871-024-02666-8.'}]}, 'descriptionModule': {'briefSummary': 'Increased days of MV are not without hazards, including barotraumas and ventilator-associated pneumonia. Similarly, premature separation of MV is associated with increased mortality secondary to adverse cardiorespiratory events. Therefore, the time of weaning should be wisely evaluated. There is growing evidence concerning respiratory muscles dysfunction that contributes to difficulty or prolonged liberation from MV.', 'detailedDescription': 'Researchers aim to evaluate the influence of adding parasternal thickening fraction to the standard weaning criteria and its impact on reintubation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* critically ill patient mechanically ventilated for 24 hours or more first spontaneous breathing trial\n\nExclusion Criteria:\n\n* patient refusal difficult ultrasound views tracheostomized patient neuromuscular disorders'}, 'identificationModule': {'nctId': 'NCT07143695', 'briefTitle': 'Parasternal Intercostal Muscle Thickening as an Additive Weaning Criterion', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Parasternal Intercostal Muscle Thickening as an Additive Weaning Criterion to Minimize Re-intubation Rate: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PIC criterion'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'patients in control will be weaning using standard criteria', 'interventionNames': ['Device: Sham parasternal intercostal thickening']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound', 'description': 'patient in this group will be weaned using standard criteria plus mean parasternal thickening fraction less than 6.5 %', 'interventionNames': ['Device: Parasternal intercostal thickening fraction']}], 'interventions': [{'name': 'Parasternal intercostal thickening fraction', 'type': 'DEVICE', 'description': 'Parasternal intercostal thickening fraction less than 6.5%', 'armGroupLabels': ['Ultrasound']}, {'name': 'Sham parasternal intercostal thickening', 'type': 'DEVICE', 'description': 'Ultrasound assessment only for purpose of blinding', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6890', 'city': 'Cairo', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mina Helmy', 'role': 'CONTACT', 'email': 'dr_mina20002010@yahoo.com', 'phone': '01275716942'}], 'facility': 'Cairo University'}], 'centralContacts': [{'name': 'Cairo university', 'role': 'CONTACT', 'email': 'kasralainirec@gmail.com', 'phone': '+201275716942'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD might not be shared to protect confidentiality, maintain competitive advantage, and comply with legal or contractual restrictions'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia and critical care', 'investigatorFullName': 'Mina Adolf Helmy', 'investigatorAffiliation': 'Cairo University'}}}}