Utility of Defining ARDS and Past and Current Definitions of ARDS

NCT06159465 | Completed

• 1 other identifier: ARDS_Delphi
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Distress Syndrome, Adult; Hypoxemic Respiratory Failure; Respiratory Failure; Phenotypic Abnormality; Delphi Study

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A diverse panel of 35 to 40 Panellists from different professional disciplines, such as Internal Medicine, Intensive Care Medicine, Respiratory Medicine, Anaesthesiology, and Physiology, with experience in the field of ARDS.

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• NMC Specialty Hospital: lead

Study Sites (1)

NMC Specialty Hospital, Al Nahda

Dubai, United Arab Emirates

Location

Related Publications (10)

• 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.

  PMID: 27133972 RESULT

• 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.

  PMID: 36150099 RESULT

• 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: 10.7326/0003-4819-141-6-200409210-00009.

  PMID: 15381517 RESULT

• 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: 22797452 RESULT

• 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.

  PMID: 36070787 RESULT

• 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.

  PMID: 16139155 RESULT

• 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, Ramakrishnan N, Ranieri VM, Riviello ED, Rubin E, Slutsky AS, Thompson BT, Twagirumugabe T, Ware LB, Wick KD. A New Global Definition of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2024 Jan 1;209(1):37-47. doi: 10.1164/rccm.202303-0558WS.

  PMID: 37487152 RESULT

• 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.

  PMID: 34322364 RESULT

• 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 Definition. Am J Respir Crit Care Med. 2016 Jan 1;193(1):52-9. doi: 10.1164/rccm.201503-0584OC.

  PMID: 26352116 RESULT

• Nasa P, Bos LD, Estenssoro E, van Haren FM, Serpa Neto A, Rocco PR, Slutsky AS, Schultz MJ. Consensus statements on the utility of defining ARDS and the utility of past and current definitions of ARDS-protocol for a Delphi study. BMJ Open. 2024 Apr 25;14(4):e082986. doi: 10.1136/bmjopen-2023-082986.

  PMID: 38670604 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Prashant Nasa, MD EDIC

  HOD, Critical Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HOD, Critical Care Medicine

Study Record Dates

• First Submitted: November 25, 2023
• First Posted: December 6, 2023
• Study Start: December 13, 2023
• Primary Completion: April 7, 2024
• Study Completion: April 15, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)