Respiratory Distress Syndrome, AdultDelphi_ARDSNCT06159465
Utility of Defining ARDS and Past and Current Definitions of ARDS
An observational study of Respiratory Distress Syndrome, Adult and Hypoxemic Respiratory Failure, run by NMC Specialty Hospital at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Hypoxemic Respiratory Failure, Respiratory Failure
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 13 Dec 2023to 15 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
NMC Specialty Hospital, Al Nahda
Dubai
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome, Adult, Hypoxemic Respiratory Failure, Respiratory Failure, Phenotypic Abnormality, Delphi Study
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start13 Dec 2023
- Primary completion7 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMC Specialty Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prashant Nasa, NMC Specialty Hospital
- Investigators
- Prashant Nasa, MD EDIC, Principal investigator, HOD, Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159465
- Sponsor's protocol ID
- ARDS_Delphi
- Acronym
- Delphi_ARDS
- Status last verified
- Apr 2024
- First submitted
- 25 Nov 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised reports of the Delphi rounds will be shared with original publication.
Publications
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.
PubMed 27133972Ranieri 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.
PubMed 36150099Esteban 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.
PubMed 15381517ARDS 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.
PubMed 22797452Bos 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.
PubMed 36070787Ferguson 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.
PubMed 16139155Matthay 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.
PubMed 37487152Nasa 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.
PubMed 34322364Riviello 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.
PubMed 26352116Nasa 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.
PubMed 38670604
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consensus Statements on the Utility of Defining ARDS and the Utility of Past and Current Definitions of ARDS--Protocol for a Delphi Study
- ClinicalTrials.gov ID
- NCT06159465
- Acronym / sponsor ID
- Delphi_ARDS / ARDS_Delphi
- Conditions
- Respiratory Distress Syndrome, Adult, Hypoxemic Respiratory Failure, Respiratory Failure, Phenotypic Abnormality, Delphi Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NMC Specialty HospitalUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 7 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Results publication: PubMed 27133972Sweeney 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.
- Results publication: PubMed 36150099Ranieri 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.
- Results publication: PubMed 15381517Esteban 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.
- Results publication: PubMed 22797452ARDS 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.
- Results publication: PubMed 36070787Bos 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.
- Results publication: PubMed 16139155Ferguson 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.
- Results publication: PubMed 37487152Matthay 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.
- Results publication: PubMed 34322364Nasa 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.
- Results publication: PubMed 26352116Riviello 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.
- Derived from this study: PubMed 38670604Nasa 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.
- Individual participant dataSharing planned: No. Anonymised reports of the Delphi rounds will be shared with original publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prashant Nasa, MD EDIC principal investigator
HOD, Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Adult and Hypoxemic Respiratory Failure, run by NMC Specialty Hospital at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus on the conceptual framework of ARDS, (time frame: 3-4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06159465, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.