Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT07067502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Biphasic Cuirass Ventilation Compared to Non Invasive Ventilation in High Risk Extubations
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-07-14', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to assess for non-inferiority of Biphasic cuirass ventilator compared to Non invasive ventilator in high risk extubations.', 'timeFrame': '1 year', 'description': 'Primary outcome will try to assess for non-inferiority of Biphasic cuirass ventilator compared to Non invasive ventilator in high risk extubations - In other words we are comparing and calculating the rate of re-intubations in these patients in the two arms viz. Standard of care Non Invasive Positive Pressure ventilation vs intervention arm using the Biphasic Cuirass Ventilation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Respiratory Failure', 'Extubation Failure']}, 'referencesModule': {'references': [{'pmid': '24323843', 'type': 'BACKGROUND', 'citation': 'Burns KE, Meade MO, Premji A, Adhikari NK. Noninvasive positive-pressure ventilation as a weaning strategy for intubated adults with respiratory failure. Cochrane Database Syst Rev. 2013 Dec 9;2013(12):CD004127. doi: 10.1002/14651858.CD004127.pub3.'}, {'pmid': '16737982', 'type': 'BACKGROUND', 'citation': 'El-Solh AA, Aquilina A, Pineda L, Dhanvantri V, Grant B, Bouquin P. Noninvasive ventilation for prevention of post-extubation respiratory failure in obese patients. Eur Respir J. 2006 Sep;28(3):588-95. doi: 10.1183/09031936.06.00150705. Epub 2006 May 31.'}, {'pmid': '16224108', 'type': 'BACKGROUND', 'citation': 'Ferrer M, Valencia M, Nicolas JM, Bernadich O, Badia JR, Torres A. Early noninvasive ventilation averts extubation failure in patients at risk: a randomized trial. Am J Respir Crit Care Med. 2006 Jan 15;173(2):164-70. doi: 10.1164/rccm.200505-718OC. Epub 2005 Oct 13.'}, {'pmid': '16276167', 'type': 'BACKGROUND', 'citation': 'Nava S, Gregoretti C, Fanfulla F, Squadrone E, Grassi M, Carlucci A, Beltrame F, Navalesi P. Noninvasive ventilation to prevent respiratory failure after extubation in high-risk patients. Crit Care Med. 2005 Nov;33(11):2465-70. doi: 10.1097/01.ccm.0000186416.44752.72.'}, {'pmid': '28860265', 'type': 'BACKGROUND', 'citation': 'Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.'}]}, 'descriptionModule': {'briefSummary': 'subjects on mechanical ventilator who are about to be extubated to Non invasive ventilation because the physician thinks they are high risk for failure will be approached and consented for our study. Once randomized they will either be on the standard of care Non invasive arm or the intervention arm which would mean they are placed on the Biphasic cuirass ventilation.', 'detailedDescription': 'We are planning on conducting a pilot study to assess if Biphasic cuirass ventilator is non inferior to Non invasive ventilation in high risk patients who are usually extubated to Non Invasive ventilation per current standard of care.\n\nWe will identify daily in our Medical Intensive care unit patients who have passed their spontaneous breathing trials and are being planned on being extubated to Non invasive ventilation per their treating Physician and will screen them for suitability and if so then one of our study team will approach patient and or their durable power of attorney and explain about our study and possible risks vs benefit and if they are agreeable will get a written consent and then they are randomized to either the Non invasive arm (per current standard of care) vs Biphasic cuirass ventilation arm (intervention arm).\n\nWe plan on assessing them per current standard of care with blood gas and other routine standard laboratory and or imaging. The subjects will not be compensated and they will be made aware of this upfront. Also their participation is completely voluntary and they will not get any additonal charge for taking part in the study. Assuming they tolerate the biphasic cuirass ventilator we anticipate them being on it anywere from 1-4 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High risk extubation patients in the Medical Intensive care units who are being thought to be placed on non invasive ventilator post extubation.\n\nExclusion Criteria:\n\n* Age \\<18 or \\>80\n* Pregnant\n* Inmate/Prisoner\n* Chest wall defects\n* BMI \\>50\n* History of Diaphragmatic paralysis\n* History of Neuromuscular disease\n* Contraindication to study device (open chest wound, flail chest, complex thoracic surgeries in the past)'}, 'identificationModule': {'nctId': 'NCT07067502', 'briefTitle': 'Impact of Biphasic Cuirass Ventilation Compared to Non Invasive Ventilation in High Risk Extubations', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Impact of Biphasic Cuirass Ventilation Compared to Non-Invasive Ventilation in High Risk Extubations', 'orgStudyIdInfo': {'id': '455329'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non Invasive ventilator arm (per current standard of care)', 'description': 'per current standard of care', 'interventionNames': ['Device: Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm']}, {'type': 'EXPERIMENTAL', 'label': 'Biphasic cuirass ventilator arm', 'description': 'patients in this arm will be the intervention arm and will be placed on the Biphasic cuirass ventilator.', 'interventionNames': ['Device: Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm']}], 'interventions': [{'name': 'Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm', 'type': 'DEVICE', 'description': 'As opposed to patients being placed on Non invasive ventilation (CPAP or BiPAP) the intervention arm patients will be placed on the Biphasic cuirass ventilator which is a form of negative pressure ventilator.', 'armGroupLabels': ['Biphasic cuirass ventilator arm', 'Non Invasive ventilator arm (per current standard of care)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dennis B Chairman, MD', 'role': 'CONTACT', 'email': 'chairmand@umsystem.edu', 'phone': '573 884 1057'}, {'name': 'Tamar Gubeladze, MD', 'role': 'CONTACT', 'email': 'gubeladzet@health.missouri.edu', 'phone': '573 884 0808'}], 'overallOfficials': [{'name': 'Dennis B Chairman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'T'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "we don't need individual personalized data as most data will be grouped in either arms and would include age sex BMI and disease condition and their personalized data are not necessary for the research paper."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hayek Medical', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dennis Chairman', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}