Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT04507802
Status:
UNKNOWN
Last Update Posted:
2020-08-11
First Post:
2020-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2020-08-07', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for Endotracheal Intubation', 'timeFrame': '6 weeks', 'description': 'Number of patients requiring endotracheal intubation after application of helmet device'}], 'secondaryOutcomes': [{'measure': 'Improvement in Oxygen Saturation', 'timeFrame': '2 weeks', 'description': 'Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100'}, {'measure': 'Ventilator-free Days', 'timeFrame': '28 days', 'description': 'Duration of mechanical ventilation via endotracheal tube'}, {'measure': 'Intensive Care Unit Length of Stay', 'timeFrame': '4 weeks', 'description': 'Number of days admitted to intensive care unit'}, {'measure': 'Overall Mortality', 'timeFrame': '90 days', 'description': 'Death from any cause during hospitalization at time of enrollment'}, {'measure': 'Need for Proning', 'timeFrame': 'up to 24 weeks', 'description': 'Need for proning during the hospital stay'}, {'measure': 'Intensive Care Unit Mortality', 'timeFrame': '28 days', 'description': 'Death from any cause during ICU hospitalization at time of enrollment'}, {'measure': 'Patient Tolerability', 'timeFrame': '28 days from randomization', 'description': 'the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Respiratory Distress Syndrome', 'Noninvasive Ventilation', 'Corona Virus Disease', 'Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '15166842', 'type': 'BACKGROUND', 'citation': 'Frutos-Vivar F, Nin N, Esteban A. Epidemiology of acute lung injury and acute respiratory distress syndrome. Curr Opin Crit Care. 2004 Feb;10(1):1-6. doi: 10.1097/00075198-200402000-00001.'}, {'pmid': '12441753', 'type': 'BACKGROUND', 'citation': 'Estenssoro E, Dubin A, Laffaire E, Canales H, Saenz G, Moseinco M, Pozo M, Gomez A, Baredes N, Jannello G, Osatnik J. Incidence, clinical course, and outcome in 217 patients with acute respiratory distress syndrome. Crit Care Med. 2002 Nov;30(11):2450-6. doi: 10.1097/00003246-200211000-00008.'}, {'pmid': '26903337', 'type': 'BACKGROUND', 'citation': 'Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.'}, {'pmid': '22797452', 'type': 'BACKGROUND', 'citation': 'ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.'}, {'pmid': '22926653', 'type': 'BACKGROUND', 'citation': 'Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM. The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. doi: 10.1007/s00134-012-2682-1. Epub 2012 Aug 25.'}, {'pmid': '3492876', 'type': 'BACKGROUND', 'citation': 'Greene R, Lind S, Jantsch H, Wilson R, Lynch K, Jones R, Carvalho A, Reid L, Waltman AC, Zapol W. Pulmonary vascular obstruction in severe ARDS: angiographic alterations after i.v. fibrinolytic therapy. AJR Am J Roentgenol. 1987 Mar;148(3):501-8. doi: 10.2214/ajr.148.3.501.'}, {'pmid': '23709194', 'type': 'BACKGROUND', 'citation': 'Hess DR. Noninvasive ventilation for acute respiratory failure. Respir Care. 2013 Jun;58(6):950-72. doi: 10.4187/respcare.02319.'}, {'pmid': '23054404', 'type': 'BACKGROUND', 'citation': 'Berg KM, Clardy P, Donnino MW. Noninvasive ventilation for acute respiratory failure: a review of the literature and current guidelines. Intern Emerg Med. 2012 Dec;7(6):539-45. doi: 10.1007/s11739-012-0856-z. Epub 2012 Sep 28.'}, {'pmid': '22318634', 'type': 'BACKGROUND', 'citation': 'Carrillo A, Gonzalez-Diaz G, Ferrer M, Martinez-Quintana ME, Lopez-Martinez A, Llamas N, Alcazar M, Torres A. Non-invasive ventilation in community-acquired pneumonia and severe acute respiratory failure. Intensive Care Med. 2012 Mar;38(3):458-66. doi: 10.1007/s00134-012-2475-6. Epub 2012 Feb 9.'}, {'pmid': '24215648', 'type': 'BACKGROUND', 'citation': 'Thille AW, Contou D, Fragnoli C, Cordoba-Izquierdo A, Boissier F, Brun-Buisson C. Non-invasive ventilation for acute hypoxemic respiratory failure: intubation rate and risk factors. Crit Care. 2013 Nov 11;17(6):R269. doi: 10.1186/cc13103.'}, {'pmid': '17133177', 'type': 'BACKGROUND', 'citation': 'Antonelli M, Conti G, Esquinas A, Montini L, Maggiore SM, Bello G, Rocco M, Maviglia R, Pennisi MA, Gonzalez-Diaz G, Meduri GU. A multiple-center survey on the use in clinical practice of noninvasive ventilation as a first-line intervention for acute respiratory distress syndrome. Crit Care Med. 2007 Jan;35(1):18-25. doi: 10.1097/01.CCM.0000251821.44259.F3.'}, {'pmid': '14982647', 'type': 'BACKGROUND', 'citation': 'Schwartz AR, Kacmarek RM, Hess DR. Factors affecting oxygen delivery with bi-level positive airway pressure. Respir Care. 2004 Mar;49(3):270-5.'}, {'pmid': '27179847', 'type': 'BACKGROUND', 'citation': 'Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2435-41. doi: 10.1001/jama.2016.6338.'}, {'pmid': '33530249', 'type': 'DERIVED', 'citation': 'Khatib MY, Peediyakkal MZ, Elshafei MS, Elzeer HS, Ananthegowda DC, Shahen MA, Abdaljawad WI, Shaik KS, Kannappilly N, Mohamed AS, Soliman AA, Nashwan AJ. Comparison of the clinical outcomes of non-invasive ventilation by helmet vs facemask in patients with acute respiratory distress syndrome. Medicine (Baltimore). 2021 Jan 29;100(4):e24443. doi: 10.1097/MD.0000000000024443.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy of noninvasive ventilation with helmet in reducing endotracheal intubation rates in comparison with Noninvasive Ventilation (NIV) facemask among patients with Acute Respiratory Distress Syndrome (ARDS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with (Acute Respiratory Distress Syndrome) ARDS as per Berlin definition\n* Age: 18 and more\n\nExclusion Criteria:\n\n* Patients with altered sensorium \\[Glasgow Coma Scale (GCS) less than 13\\]\n* Pregnancy\n* Hemodynamic instability\n* Morbidly obese\n* Patients with tracheostomy\n* Severe acidosis \\[PH less than 7.15\\]\n* Patients with glaucoma\n* Patients with history of vertigo'}, 'identificationModule': {'nctId': 'NCT04507802', 'briefTitle': 'Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hamad Medical Corporation'}, 'officialTitle': 'Comparison of The Clinical Outcomes of Non-Invasive Ventilation by Helmet vs Facemask in Patients With Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'MRC-01-20-616'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non invasive ventilation via helmet', 'description': 'Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.', 'interventionNames': ['Device: Non invasive ventilation via helmet']}, {'type': 'NO_INTERVENTION', 'label': 'Non invasive ventilation via facemask', 'description': 'Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask'}], 'interventions': [{'name': 'Non invasive ventilation via helmet', 'type': 'DEVICE', 'description': 'Patients requiring long hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet', 'armGroupLabels': ['Non invasive ventilation via helmet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Doha', 'country': 'Qatar', 'contacts': [{'name': 'Abdulqadir J. Nashwan, MSc', 'role': 'CONTACT', 'email': 'anashwan@hamad.qa'}, {'name': 'Ahmed S. Mohamed, BSc', 'role': 'CONTACT', 'email': 'AMohamed52@hamad.qa'}, {'name': 'Mohamad Y Khatib, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mohamed Z Peediyakkal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Moustafa S Elshafei, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hani S Elzeer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dore C Ananthegowda, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Muhsen A Shahen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wael I Abdaljawad, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karimulla S Shaik, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nevin Kannappilly, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed S Mohamed, BSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed A Soliman, BSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Abdulqadir J Nashwan, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hazm Mebaireek General Hospital (HMGH)', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}], 'centralContacts': [{'name': 'Mohamed Z Peediyakkal, MD', 'role': 'CONTACT', 'email': 'MPeediyakkal2@hamad.qa', 'phone': '0097450742399'}, {'name': 'Abdulqadir J Nashwan, MSc', 'role': 'CONTACT', 'email': 'anashwan@hamad.qa', 'phone': '0097466473549'}], 'overallOfficials': [{'name': 'Mohamad Y Khatib, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamad Medical Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamad Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}