Respiratory Failure Clinical Trial
— Delphi_ARDSOfficial title:
Consensus Statements on the Utility of Defining ARDS and the Utility of Past and Current Definitions of ARDS--Protocol for a Delphi Study
Verified date | April 2024 |
Source | NMC Specialty Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Acute Respiratory Distress Syndrome (ARDS), marked by acute hypoxemia and bilateral pulmonary infiltrates, has undergone multiple definitions over the years. Challenges persist regarding the ARDS definitions, leading to various revisions. Through the Delphi study, the investigators aims to gather global opinions on the conceptual framework of ARDS, assess the utility of current and past definitions, and explore the role of subphenotyping. The diverse panel's collective expertise will contribute valuable insights for refining future ARDS definitions and enhancing clinical management.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 15, 2024 |
Est. primary completion date | April 7, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - At least 5 years of clinical experience as a staff member, with care for AHRF or ARDS patients or preclinical expertise (of more than 5 years) in AHRF or ARDS; - At least 5 publications (original studies) as a leading or senior author or member of the steering committee of an observational study or a randomised controlled trial in AHRF or ARDS; Exclusion Criteria: - Not more than 25% of panellists from the previous or current definitions of ARDS (including the Berlin Definition of ARDS, the Kigali Modification of the Definition of ARDS, and the New Global Definition of ARDS) - Not more than 70% of the panellists from each sex; and from each of high and low-middle-income countries |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | NMC Specialty Hospital, Al Nahda | Dubai |
Lead Sponsor | Collaborator |
---|---|
NMC Specialty Hospital |
United Arab Emirates,
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. — View Citation
Bos LDJ, Ware LB. Acute respiratory distress syndrome: causes, pathophysiology, and phenotypes. Lancet. 2022 Oct 1;400(10358):1145-1156. doi: 10.1016/S0140-6736(22)01485-4. Epub 2022 Sep 4. — View Citation
Esteban A, Fernandez-Segoviano P, Frutos-Vivar F, Aramburu JA, Najera L, Ferguson ND, Alia I, Gordo F, Rios F. Comparison of clinical criteria for the acute respiratory distress syndrome with autopsy findings. Ann Intern Med. 2004 Sep 21;141(6):440-5. doi — View Citation
Ferguson ND, Davis AM, Slutsky AS, Stewart TE. Development of a clinical definition for acute respiratory distress syndrome using the Delphi technique. J Crit Care. 2005 Jun;20(2):147-54. doi: 10.1016/j.jcrc.2005.03.001. — View Citation
Matthay MA, Arabi Y, Arroliga AC, Bernard G, Bersten AD, Brochard LJ, Calfee CS, Combes A, Daniel BM, Ferguson ND, Gong MN, Gotts JE, Herridge MS, Laffey JG, Liu KD, Machado FR, Martin TR, McAuley DF, Mercat A, Moss M, Mularski RA, Pesenti A, Qiu H, Ramak — View Citation
Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021 Jul 20;11(4):116-129. doi: 10.5662/wjm.v11.i4.116. eCollection 2021 Jul 20. — View Citation
Ranieri VM, Rubenfeld G, Slutsky AS. Rethinking Acute Respiratory Distress Syndrome after COVID-19: If a "Better" Definition Is the Answer, What Is the Question? Am J Respir Crit Care Med. 2023 Feb 1;207(3):255-260. doi: 10.1164/rccm.202206-1048CP. — View Citation
Riviello ED, Kiviri W, Twagirumugabe T, Mueller A, Banner-Goodspeed VM, Officer L, Novack V, Mutumwinka M, Talmor DS, Fowler RA. Hospital Incidence and Outcomes of the Acute Respiratory Distress Syndrome Using the Kigali Modification of the Berlin Definit — View Citation
Sweeney RM, McAuley DF. Acute respiratory distress syndrome. Lancet. 2016 Nov 12;388(10058):2416-2430. doi: 10.1016/S0140-6736(16)00578-X. Epub 2016 Apr 28. Erratum In: Lancet. 2016 Nov 12;388(10058):2354. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Consensus on the conceptual framework of ARDS, | Diverse group of panelist across the globe based on pre-specified qualification criteria and will conduct iterative Delphi rounds to generate consensus on the conceptual framework of ARDS. | 3-4 months | |
Primary | Consensus on the utility of current and past definitions, | Diverse group of panelist across the globe based on pre-specified qualification criteria and will conduct iterative Delphi rounds to generate consensus on the utility of current and past definitions of ARDS. | 3-4 months | |
Primary | Consensus on the role of subphenotyping in ARDS | Diverse group of panelist across the globe based on pre-specified qualification criteria and will conduct iterative Delphi rounds to generate consensus on the role of subphenotyping in ARDS | 3-4 months |
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