Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT04534569
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2020-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2020-08-30', 'studyFirstSubmitQcDate': '2020-08-31', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consensus using participating experts opinions.', 'timeFrame': '20 days', 'description': 'Survey Questionnaire containing seven point Likert scale and multiple choice questions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Acute Respiratory Failure', 'Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '28716645', 'type': 'BACKGROUND', 'citation': 'Narendra DK, Hess DR, Sessler CN, Belete HM, Guntupalli KK, Khusid F, Carpati CM, Astiz ME, Raoof S. Update in Management of Severe Hypoxemic Respiratory Failure. Chest. 2017 Oct;152(4):867-879. doi: 10.1016/j.chest.2017.06.039. Epub 2017 Jul 14.'}, {'pmid': '32822927', 'type': 'BACKGROUND', 'citation': 'Tang S, Mao Y, Jones RM, Tan Q, Ji JS, Li N, Shen J, Lv Y, Pan L, Ding P, Wang X, Wang Y, MacIntyre CR, Shi X. Aerosol transmission of SARS-CoV-2? Evidence, prevention and control. Environ Int. 2020 Nov;144:106039. doi: 10.1016/j.envint.2020.106039. Epub 2020 Aug 7.'}, {'pmid': '33726819', 'type': 'DERIVED', 'citation': 'Nasa P, Azoulay E, Khanna AK, Jain R, Gupta S, Javeri Y, Juneja D, Rangappa P, Sundararajan K, Alhazzani W, Antonelli M, Arabi YM, Bakker J, Brochard LJ, Deane AM, Du B, Einav S, Esteban A, Gajic O, Galvagno SM Jr, Guerin C, Jaber S, Khilnani GC, Koh Y, Lascarrou JB, Machado FR, Malbrain MLNG, Mancebo J, McCurdy MT, McGrath BA, Mehta S, Mekontso-Dessap A, Mer M, Nurok M, Park PK, Pelosi P, Peter JV, Phua J, Pilcher DV, Piquilloud L, Schellongowski P, Schultz MJ, Shankar-Hari M, Singh S, Sorbello M, Tiruvoipati R, Udy AA, Welte T, Myatra SN. Expert consensus statements for the management of COVID-19-related acute respiratory failure using a Delphi method. Crit Care. 2021 Mar 16;25(1):106. doi: 10.1186/s13054-021-03491-y.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to achieve experts consensus on respiratory interventions in management of COVID-19 related acute respiratory failure (C-ARF).', 'detailedDescription': 'The investigators aim to achieve experts consensus on respiratory interventions in management of COVID-19 related acute respiratory failure (C-ARF). The pandemic of COVID-19 is unique in terms of a multitude of patients suffering from ARF and requiring invasive mechanical ventilation with single underlying inciting etiology.The experts have given divergent opinions on respiratory support of C-ARF which may have confused physicians globally.\n\nThe investigators are going to use a modified Delphi based methodology involving global participating experts. The objective is to achieve consensus statement on the management of C-ARF using "collective intelligence".\n\nThe whole process of this study will be done in the form of two-three rounds of Google Forms-based Delphi surveys. In this survey questionnaire, the investigators have prepared statements on the concern areas in the respiratory support of C-ARF. The survey has been divided into five sections related to C-ARF management. The majority of these statements are to be rated on Likert scale and others have multiple choices. There is an option for collecting participating experts comments in provided open space in round one which will be considered during round two questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Global Experts in Respiratory or Critical Care Medicine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: (All the three criteria should be there) H index more than 10; one or more publication on respiratory failure in indexed journal; actively involved in management of COVID-19 related acute respiratory failure.\n\nExclusion Criteria:\n\nNot meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT04534569', 'briefTitle': 'Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)', 'organization': {'class': 'OTHER', 'fullName': 'NMC Specialty Hospital'}, 'officialTitle': 'Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF) Using Modified Delphi Methodology', 'orgStudyIdInfo': {'id': 'C19ARFstudy'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Experts consensus', 'type': 'OTHER', 'description': 'Consensus opinion using Delphi Methodology'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7832', 'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'NMC Specialty Hospital', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NMC Specialty Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Critical Care Medicine', 'investigatorFullName': 'Prashant Nasa', 'investigatorAffiliation': 'NMC Specialty Hospital'}}}}