SARS (Severe Acute Respiratory Syndrome)NCT04374734
Quantification of Radiological Pulmonary Involvement in Acute Respiratory Failure
An observational study of SARS (Severe Acute Respiratory Syndrome), run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Acute respiratory failure (ARF) is a common condition and a common reason for urgent medical consultation. Assessing the extent of respiratory impairment is important to improve the management of patients with ARF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS (Severe Acute Respiratory Syndrome)
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2020to 30 Jun 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients presenting a situation at risk of acute respiratory failure
Who may be able to join
- Patients over 18 years of age
- Presenting a situation at risk of acute respiratory failure
- Requiring thorax imaging when they were treated.
Who cannot join
- Patients with anatomically incomplete thoracic imaging (e.g., technical acquisition error).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automated Quantification of Radiological Pulmonary Involvement in Acute Respiratory Failure
Acute respiratory failure (ARF) is a common condition and a common reason for urgent medical consultation. Assessing the extent of respiratory impairment is important to improve the management of patients with ARF. When Acute respiratory failure is caused by pathology of the pulmonary parenchyma, quantification of pulmonary radiographic involvement may be a component of the initial assessment of severity. This radiographic quantification would only be usable in clinical routine if it can be automated and provide a real-time result.
The objective of this work is to assess the feasibility of an automated technique for quantifying radiological lung damage in situations of known or potential ARF.
- Conditions
- SARS (Severe Acute Respiratory Syndrome)
- Keywords
- SARS, Severe Acute Respiratory Syndrome, Automated quantification, Lung volume, Thorax imaging
- Medical subject headings
- Severe Acute Respiratory Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of the relationship between severe forms of ARF and the extent of lung involvement
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start5 Apr 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS (Severe Acute Respiratory Syndrome)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374734
- Sponsor's protocol ID
- 7791
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2020
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Quantification of Radiological Pulmonary Involvement in Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT04374734
- Acronym / sponsor ID
- 7791
- Conditions
- SARS (Severe Acute Respiratory Syndrome)
- Keywords
- SARS, Severe Acute Respiratory Syndrome, Automated quantification, Lung volume, Thorax imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 5 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 5 May 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.
Acute respiratory failure (ARF) is a common condition and a common reason for urgent medical consultation. Assessing the extent of respiratory impairment is important to improve the management of patients with ARF. When Acute respiratory failure is caused by pathology of the pulmonary parenchyma, quantification of pulmonary radiographic involvement may be a component of the initial assessment of severity. This radiographic quantification would only be usable in clinical routine if it can be automated and provide a real-time result.
The objective of this work is to assess the feasibility of an automated technique for quantifying radiological lung damage in situations of known or potential ARF.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients presenting a situation at risk of acute respiratory failure
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Presenting a situation at risk of acute respiratory failure
- Requiring thorax imaging when they were treated.
Key exclusion criteria (1 listed)
- Patients with anatomically incomplete thoracic imaging (e.g., technical acquisition error).
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
Retrospective study of the relationship between severe forms of ARF and the extent of lung involvement
Time frame: 2 months
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 7 Oct 2021.
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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 SARS (Severe Acute Respiratory Syndrome), run by University Hospital, Strasbourg, France at 1 site in France.
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 3 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 7 Oct 2021. 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 France. 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?
Retrospective study of the relationship between severe forms of ARF and the extent of lung involvement (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2021.