Utility of Defining ARDS and Past and Current Definitions of ARDS (Delphi_ARDS)

April 15, 2024 updated by: Prashant Nasa, NMC Specialty Hospital

Consensus Statements on the Utility of Defining ARDS and the Utility of Past and Current Definitions of ARDS--Protocol for a Delphi Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Acute respiratory distress syndrome (ARDS), characterized by acute hypoxemia and bilateral pulmonary infiltrates that are not attributable to heart failure, has seen multiple definitions over the years. The primary purpose of a formal ARDS definition is to identify a homogenous cohort among patients with acute hypoxemic respiratory failure (AHRF), facilitating research, therapeutic trials, and prognostic assessment.

The validity of the conceptual framework of ARDS, however, has been challenged and uncertainties exist regarding the utility of ARDS definitions. Amongst other reasons, the lack of consensus on the conceptual model and diagnostic criteria have led to numerous revisions of the definition of ARDS. Furthermore, categorizing ARDS to assess treatment effects has had limited success, and subphenotypes have been proposed in part to address this issue.

The Delphi methodology has been used to generate expert consensus on components of the ARDS definition. Consensus process through a Delphi minimizes individual or professional dominance and peer pressure bias through a careful selection of experts, anonymous voting and monitoring attrition rates during Delphi rounds. A rigorous Delphi would be useful to assess the utility of the conceptual model of ARDS, past and current definitions of ARDS, and the value of categorisation of ARDS by means of subphenotyping.

Through this Delphi study, the investigators intend to assess the challenges in the conceptual framework of ARDS, past and current ARDS definitions, ongoing efforts in ARDS categorization and will develop consensus statements for future research in the definition and subphenotyping of ARDS.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consensus on the conceptual framework of ARDS,
Time Frame: 3-4 months
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,
Time Frame: 3-4 months
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
Time Frame: 3-4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NMC Specialty Hospital

Investigators

  • Principal Investigator: Prashant Nasa, MD EDIC, HOD, Critical Care Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2023

Primary Completion (Actual)

April 7, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

November 25, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARDS_Delphi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonymised reports of the Delphi rounds will be shared with original publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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