Acute Respiratory FailureCHECKIRA-COVIDNCT04791241
A Check-list Including Lung Ultrasound for ED Patients With ARF
A study testing check-list including lung ultrasound in people with Acute Respiratory Failure, run by Centre Hospitalier Metropole Savoie at 3 sites in France.
Trial summary
The aim of the study is to evaluate if a check-list including lung ultrasonography can help to identify the etiology of the acute respiratory failure of patients managed at the emergency room. Adult patients admitted to the emergency room for acute respiratory failure will be offered the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- check-list including lung ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Mar 2021to 4 Jan 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with acute respiratory failure table (SpO2 90% in ambient air or need more than 3 L/min of oxygen to have SpO2 > 92% AND/OR signs of respiratory struggle sign AND/OR respiratory rate control > 25 cycles/minute AND/OR cyanosis)
- Over 18 years old
Who cannot join
- Pregnant, Parturising or Breastfeeding Women
- Patient who has already participated in the study in the previous 7 days
Trial locations and contacts
3 sites in 1 country.
France3 sites
CH Annecy Genevois
Annecy, 74370
Centre Hospitalier Metropole Savoie
Chambéry, 73000
CHUGA
Grenoble, 38000
About this study
Official title: Evaluation of a Check-list Including Lung Ultrasound for the Management of Patients With Acute Respiratory Failure at the Emergency Department During the COVID-19 Era
The aim of the study is to evaluate if a check-list including lung ultrasonography can help to identify the etiology of the acute respiratory failure of patients managed at the emergency room.
Adult patients admitted to the emergency room for acute respiratory failure will be offered the study. The emergency physician will perform a systematic examination using a checklist, including pulmonary embolism prediction scores, structured clinical examination and lung ultrasound, in order to establish a diagnostic hypothesis.
Read more
A diagnostic hypothesis will be made after completion of the checklist. The emergency physician can perform additional examinations and treatment after completion of the checklist.
The final diagnosis will be checked by an adjudication committee which will have all the documents established during the emergency room consultation and any hospitalization following this hospitalization.
The main outcome will be the concordance rate between the diagnosis after the check-list and the final diagnosis.
- Conditions
- Acute Respiratory Failure
- Being tested
- check-list including lung ultrasound
- Keywords
- Covid19, Acute Respiratory Failure, Ultrasound, Checklist, Emergency, Diagnosis
- Medical subject headings
- COVID-19, Emergencies, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
check-list including lung ultrasoundOther
The investigator will follow the checklist which includes the collection of anamnestic data and clinical signs, the performance of a pulmonary embolism clinical probability score and a cardiopulmonary ultrasound with count -standardized rendering. After completing this checklist, the investigator will note their diagnosis (list of proposals on the data collection sheet), the treatments started (closed list of therapeutic classes). If he orders other tests, he will write them down and then note the diagnosis made and the treatments prescribed after obtaining the results of these tests.
The therapeutic management of patients compared to the usual care in the respective departments may be modified depending on the results of the cardiopulmonary ultrasound . The emergency physician may initiate therapy before the results of additional examinations that he would have usually performed without cardiopulmonary ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| check-list with ultrasound | Experimental | check-list including lung ultrasound for the management of patients with acute respiratory failure at the emergency department during the COVID-19 era Receives: Other: check-list including lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between the etiology retained after using the checklist and the diagnosis retained by an adjudication committee after analysis of the entire patient file.
The adjudication committee will meet all 35 inclusions to determine the diagnosis of each patient after analysis of the complete anonymized file which will be provided by locol investigator one month after inclusion.
Measured: 1 month after inclusion
Secondary outcomes (5)
Analysis of the diagnosis retained after the checklist in patients with a final diagnosis of COVID-19; analysis of the final diagnosis in patients with a diagnosis of COVID-19 evoked after the checklist
The adjudication committee will meet periodically after analysis of the complete anonymized file to check the COVID diagnosis.
Measured: One month after inclusion
Collection of treatments started only after completion of the checklist and verification of its suitability for the diagnosis selected
All the treatments started only after completion of the checklist wil be collected prospectively and their appropriateness will be checked.
Measured: at one day
Collection of additional examinations possibly performed in the emergency unit after the completion of the checklist
All additional examinations performed after the completion of the checklist will be collected
Measured: at one day
Comparison of treatments introduced after completion of the checklist and after the other additional examinations performed at the emergency room
all treatments delivered after the completion of the checklist and after complementary exams will be collected and classified into therapeutic families (antibiotics, diuretics).
Measured: at one day
Delay between completion of the checklist and obtaining the results of any other examinations
Time between the completion of the checklist and obtaining the last result of the other examinations performed at the emergency room (except for bacterial culture)
Measured: At one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start3 Mar 2021
- Primary completion3 Jan 2022
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791241
- Sponsor's protocol ID
- 2020-A02050-39
- Acronym
- CHECKIRA-COVID
- Status last verified
- Oct 2026
- First submitted
- 22 Feb 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Check-list Including Lung Ultrasound for the Management of Patients With Acute Respiratory Failure at the Emergency Department During the COVID-19 Era
- ClinicalTrials.gov ID
- NCT04791241
- Acronym / sponsor ID
- CHECKIRA-COVID / 2020-A02050-39
- Conditions
- Acute Respiratory Failure
- Keywords
- Covid19, Acute Respiratory Failure, Ultrasound, Checklist, Emergency, Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 10 Mar 2021 (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 aim of the study is to evaluate if a check-list including lung ultrasonography can help to identify the etiology of the acute respiratory failure of patients managed at the emergency room.
Adult patients admitted to the emergency room for acute respiratory failure will be offered the study. The emergency physician will perform a systematic examination using a checklist, including pulmonary embolism prediction scores, structured clinical examination and lung ultrasound, in order to establish a diagnostic hypothesis.
A diagnostic hypothesis will be made after completion of the checklist. The emergency physician can perform additional examinations and treatment after completion of the checklist.
The final diagnosis will be checked by an adjudication committee which will have all the documents established during the emergency room consultation and any hospitalization following this hospitalization.
The main outcome will be the concordance rate between the diagnosis after the check-list and the final diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| check-list with ultrasound | Experimental | Other: check-list including lung ultrasoundcheck-list including lung ultrasound for the management of patients with acute respiratory failure at the emergency department during the COVID-19 era |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with acute respiratory failure table (SpO2 90% in ambient air or need more than 3 L/min of oxygen to have SpO2 > 92% AND/OR signs of respiratory struggle sign AND/OR respiratory rate control > 25 cycles/minute AND/OR cyanosis)
- Over 18 years old
Key exclusion criteria (2 listed)
- Pregnant, Parturising or Breastfeeding Women
- Patient who has already participated in the study in the previous 7 days
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 |
|---|---|---|
| check-list including lung ultrasoundThe investigator will follow the checklist which includes the collection of anamnestic data and clinical signs, the performance of a pulmonary embolism clinical probability score and a cardiopulmonary ultrasound with count -standardized rendering. After completing this checklist, the investigator will note their diagnosis (list of proposals on the data collection sheet), the treatments started (closed list of therapeutic classes). If he orders other tests, he will write them down and then note the diagnosis made and the treatments prescribed after obtaining the results of these tests. The therapeutic management of patients compared to the usual care in the respective departments may be modified depending on the results of the cardiopulmonary ultrasound . The emergency physician may initiate therapy before the results of additional examinations that he would have usually performed without cardiopulmonary ultrasound. | Other | check-list with ultrasound |
Primary outcome
Agreement between the etiology retained after using the checklist and the diagnosis retained by an adjudication committee after analysis of the entire patient file.
Time frame: 1 month after inclusion
The adjudication committee will meet all 35 inclusions to determine the diagnosis of each patient after analysis of the complete anonymized file which will be provided by locol investigator one month after inclusion.
5 secondary outcomes
Analysis of the diagnosis retained after the checklist in patients with a final diagnosis of COVID-19; analysis of the final diagnosis in patients with a diagnosis of COVID-19 evoked after the checklist
Time frame: One month after inclusion
Collection of treatments started only after completion of the checklist and verification of its suitability for the diagnosis selected
Time frame: at one day
Collection of additional examinations possibly performed in the emergency unit after the completion of the checklist
Time frame: at one day
Comparison of treatments introduced after completion of the checklist and after the other additional examinations performed at the emergency room
Time frame: at one day
Delay between completion of the checklist and obtaining the results of any other examinations
Time frame: At one day
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 2026.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing check-list including lung ultrasound in people with Acute Respiratory Failure, run by Centre Hospitalier Metropole Savoie at 3 sites 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 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Agreement between the etiology retained after using the checklist and the diagnosis retained by an adjudication committee after analysis of the entire patient file. (time frame: 1 month after inclusion). 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 8 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.