Covid19NCT04534569
Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
An observational study of Covid19 and Acute Respiratory Failure, run by NMC Specialty Hospital at 1 site in United Arab Emirates.
Trial summary
The investigators aim to achieve experts consensus on respiratory interventions in management of COVID-19 related acute respiratory failure (C-ARF). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covid19, Acute Respiratory Failure, Acute Respiratory Distress Syndrome
- What is being tested?
- Experts consensus
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 4 Sep 2020to 6 Oct 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Global Experts in Respiratory or Critical Care Medicine
Who may be able to join
None listed.
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF) Using Modified Delphi Methodology
The investigators aim to achieve experts consensus on respiratory interventions in management of COVID-19 related acute respiratory failure (C-ARF).
Read the detailed description
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.
The 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".
The 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.
- Being tested
- Experts consensus
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experts consensusOther
Consensus opinion using Delphi Methodology
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus using participating experts opinions.
Survey Questionnaire containing seven point Likert scale and multiple choice questions.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start4 Sep 2020
- Primary completion3 Oct 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Other
- Time perspective
- Prospective
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534569
- Sponsor's protocol ID
- C19ARFstudy
- Status last verified
- Oct 2020
- First submitted
- 30 Aug 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28716645Tang 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.
PubMed 32822927Nasa 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.
PubMed 33726819
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF) Using Modified Delphi Methodology
- ClinicalTrials.gov ID
- NCT04534569
- Acronym / sponsor ID
- C19ARFstudy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NMC Specialty HospitalUniversity, hospital or other
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 3 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 1 Sep 2020 (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.
The investigators aim to achieve experts consensus on respiratory interventions in management of COVID-19 related acute respiratory failure (C-ARF).
Detailed description
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.
The 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".
The 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Global Experts in Respiratory or Critical Care Medicine
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experts consensusConsensus opinion using Delphi Methodology | Other | – |
Primary outcome
Consensus using participating experts opinions.
Time frame: 20 days
Survey Questionnaire containing seven point Likert scale and multiple choice questions.
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 8 Oct 2020.
- Background: PubMed 28716645Narendra 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.
- Background: PubMed 32822927Tang 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.
- Derived from this study: PubMed 33726819Nasa 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19 and Acute 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 0 inclusion and 1 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 8 Oct 2020. 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 using participating experts opinions. (time frame: 20 days). 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 NCT04534569, which also lists 3 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 8 Oct 2020.