PneumothoraxNCT03907150
Pleurostrain: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax
An observational study of Pneumothorax, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
Trial summary
The objective of this study is to investigate whether the use of strain ultrasound can improve the lung ultrasound accuracy for the diagnosis of pneumothorax, particularly for inexperienced physicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Strain ultrasound
- How many people
- 122 participants
- Where
- 4 sitesFrance
- Study dates
- 13 Feb 2019to 20 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
- No healthy volunteers
- Adult, Older adult
Study population: Emergency Department or critical care patient who had a chest CT within 2 hours
Who may be able to join
- Age over 17 years old
- Management in an investigative centre
- Presenting a suspicion of pneumothorax
- Having had a pulmonary ultrasound scan
- Having had a CT scan within 2 hours after or before the pulmonary ultrasound
Who cannot join
- Pregnant or breastfeeding women
- Persons not covered by a social security scheme
- Persons deprived of their liberty
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under the protection of justice, guardianship or curatorship
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- Patient refuses to participate
- It is impossible to give informed information about
- The patient does not read French fluently
- Patient with any known pulmonary pathology pre-existing prior to the hospitalization episode
- Patient with a lung condition other than pneumothorax on a scanner
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital La Timone
Marseille, 13005
AP-HM - Hopital Nord
Marseille, 13915
CHU Nîmes
Nîmes, 30029
Nimes University hospital
Nîmes, 30029
About this study
Official title: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax: Prospective Multicenter Observational Study
The objective of this study is to investigate whether the use of strain ultrasound can improve the lung ultrasound accuracy for the diagnosis of pneumothorax, particularly for inexperienced physicians.
Read the detailed description
Prospective multi-centre diagnostic study based on the post-interpretation of recorded ultrasound loops as part of standard patient management.
- Conditions
- Pneumothorax
- Being tested
- Strain ultrasound
- Keywords
- Pont-of-Care Ultrasound
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strain ultrasoundDiagnostic test
Post-interpretation of recorded ultrasound loops
| Study group | Role | What they receive |
|---|---|---|
| Pneumothorax | Pneumothorax Receives: Diagnostic Test: Strain ultrasound | |
| Normal | Normal lung Receives: Diagnostic Test: Strain ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumothorax diagnosis by an inexperienced physician in lung ultrasound
The main endpoint will be a binary qualitative value: diagnosis of pneumothorax (yes/no) judged by inexperienced physicians performing pleural strain.
Measured: May 1, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start13 Feb 2019
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Bobbia, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907150
- Sponsor's protocol ID
- XBobbia/Pleurostrain
- Status last verified
- Jul 2020
- First submitted
- 3 Apr 2019
- Last updated
- 13 Jul 2020
- 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 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Strain Ultrasound in the Diagnosis of Pneumothorax: Prospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT03907150
- Acronym / sponsor ID
- XBobbia/Pleurostrain
- Conditions
- Pneumothorax
- Keywords
- Pont-of-Care Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 8 Apr 2019 (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 objective of this study is to investigate whether the use of strain ultrasound can improve the lung ultrasound accuracy for the diagnosis of pneumothorax, particularly for inexperienced physicians.
Detailed description
Prospective multi-centre diagnostic study based on the post-interpretation of recorded ultrasound loops as part of standard patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumothorax | – | Diagnostic Test: Strain ultrasoundPneumothorax |
| Normal | – | Diagnostic Test: Strain ultrasoundNormal lung |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency Department or critical care patient who had a chest CT within 2 hours
Key inclusion criteria (5 listed)
- Age over 17 years old
- Management in an investigative centre
- Presenting a suspicion of pneumothorax
- Having had a pulmonary ultrasound scan
- Having had a CT scan within 2 hours after or before the pulmonary ultrasound
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding women
- Persons not covered by a social security scheme
- Persons deprived of their liberty
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
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 |
|---|---|---|
| Strain ultrasoundPost-interpretation of recorded ultrasound loops | Diagnostic test | Normal, Pneumothorax |
Primary outcome
Pneumothorax diagnosis by an inexperienced physician in lung ultrasound
Time frame: May 1, 2021
The main endpoint will be a binary qualitative value: diagnosis of pneumothorax (yes/no) judged by inexperienced physicians performing pleural strain.
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 13 Jul 2020.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax, run by Centre Hospitalier Universitaire de Nīmes at 4 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 5 inclusion and 11 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 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Pneumothorax diagnosis by an inexperienced physician in lung ultrasound (time frame: May 1, 2021). 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 13 Jul 2020.