DyspneaVSCAN-DYSPNCT01818882
Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department
A study testing Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI) in people with Dyspnea, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of our study is to compare the effects of two care strategies for dyspneic patients on the length of hospital stay: (1) standard care (=contextual analysis + conventional clinical chest radiography) versus (2) standard care + pleuropulmonary ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jan 2016
- 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
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patient consulting in the emergency department for dyspnea
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient cannot read French
- The patient is pregnant, parturient, or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department: a Randomized Study
The main objective of our study is to compare the effects of two care strategies for dyspneic patients on the length of hospital stay: (1) standard care (=contextual analysis + conventional clinical chest radiography) versus (2) standard care + pleuropulmonary ultrasound.
Read the detailed description
The secondary objectives of this study are to assess the following for both arms:
A-fatality rate, B-degree of concordance between the diagnosis orientation in the emergency department and final diagnosis determined by an expert committee using patient records one month later (blind evaluation by a panel of experts) C-clinical improvement between early emergency care and later care outside the emergency department (clinical parameters = blood gases and other biological parameters) D-imaging parameters.
- Conditions
- Dyspnea
- Being tested
- Standard care, Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)
- Keywords
- Vscan, portable ultrasound, emergency care, emergency room
- Medical subject headings
- Dyspnea, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Standard care for dyspneic patients including contextual analysis, conventional clinical exam and a chest X-Ray.
Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)Device
Standard care (as described for the other intervention) + pleuropulmonary ultrasound using the Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI).
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Patients randomized to this arm will receive standard care.
Intervention: Standard care. Receives: Other: Standard care |
| Standard care + ultrasound | Experimental | Patients randomized to this arm will receive standard care + pleuropulmonary ultrasound.
Intervention: Standard care + ultrasound Receives: Other: Standard care; Device: Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay in days
Measured: 1 month
Secondary outcomes (49)
Patient deceased? yes/no
Measured: 1 month
Diagnosis in the emergency room
Measured: upon discharge from the emergency department (max 1 month)
Diagnosis given by expert committee based on patient file
Measured: 1 month
Glasgow scale
Measured: Baseline, day 0
Glasgow scale
Measured: day 3
Heart rate
Measured: baseline, day 0
Heart rate
Measured: day 3
Respiratory rate
Measured: baseline, day 0
Respiratory rate
Measured: day 3
Systolic blood pressure
Measured: baseline, day 0
Systolic blood pressure
Measured: day 3
Diastolic blood pressure
Measured: baseline, day 0
Diastolic blood pressure
Measured: day 3
Temperature
Measured: baseline, day 0
Temperature
Measured: day 3
blood pH
Measured: baseline, day 0
blood pH
Measured: day 3
CO2 arterial pressure
Measured: baseline, day 0
CO2 arterial pressure
Measured: day 3
O2 arterial pressure
Measured: baseline, day 0
O2 arterial pressure
Measured: day 3
O2 saturation
Measured: baseline, day 0
O2 saturation
Measured: day 3
Alkaline reserve
Measured: baseline, day 0
Alkaline reserve
Measured: day 3
white blood cell count
Measured: baseline, day 0
white blood cell count
Measured: day 3
C-reactive protein
Measured: baseline, day 0
C-reactive protein
Measured: day 3
Brain Natriuretic Peptide
Measured: baseline, day 0
Brain Natriuretic Peptide
Measured: day 3
hemoglobin
Measured: baseline, day 0
hemoglobin
Measured: day 3
Pulmonary x-ray, yes/no
Measured: baseline, day 0
right alveolar opacities on x-ray, yes/no
Measured: baseline, day 0
left alveolar opacities on x-ray, yes/no
Measured: baseline, day 0
right parenchymal origin on x-ray, yes/no
Measured: baseline, day 0
left parenchymal origin on x-ray, yes/no
Measured: baseline, day 0
right pleural effusion on x-ray, yes/no
Measured: baseline, day 0
left pleural effusion on x-ray, yes/no
Measured: baseline, day 0
pleuropulmonary ultrasound, yes/no
Measured: baseline, day 0
right alveolar-interstitial syndrome on ultrasound, yes/no
Measured: baseline, day 0
left alveolar-interstitial syndrome on ultrasound, yes/no
Measured: baseline, day 0
right lung consolidation on ultrasound, yes/no
Measured: baseline, day 0
left lung consolidation on ultrasound, yes/no
Measured: baseline, day 0
right pleural effusion on ultrasound, yes/no
Measured: baseline, day 0
left pleural effusion on ultrasound, yes/no
Measured: baseline, day 0
right pneumothorax on ultrasound, yes/no
Measured: baseline, day 0
left pneumothorax on ultrasound, yes/no
Measured: baseline, day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startApr 2014
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Inclusion curve too slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Bobbia, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818882
- Sponsor's protocol ID
- LOCAL/2012/XB-01
- Other IDs
- 2013-A00100-45
- Acronym
- VSCAN-DYSP
- Status last verified
- Mar 2016
- First submitted
- 23 Mar 2013
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department: a Randomized Study
- ClinicalTrials.gov ID
- NCT01818882
- Acronym / sponsor ID
- VSCAN-DYSP / LOCAL/2012/XB-01
- Conditions
- Dyspnea
- Keywords
- Vscan, portable ultrasound, emergency care, emergency room
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion curve too slow.
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Mar 2013 (estimated)
- 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 main objective of our study is to compare the effects of two care strategies for dyspneic patients on the length of hospital stay: (1) standard care (=contextual analysis + conventional clinical chest radiography) versus (2) standard care + pleuropulmonary ultrasound.
Detailed description
The secondary objectives of this study are to assess the following for both arms:
A-fatality rate, B-degree of concordance between the diagnosis orientation in the emergency department and final diagnosis determined by an expert committee using patient records one month later (blind evaluation by a panel of experts) C-clinical improvement between early emergency care and later care outside the emergency department (clinical parameters = blood gases and other biological parameters) D-imaging parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: Standard carePatients randomized to this arm will receive standard care. Intervention: Standard care. |
| Standard care + ultrasound | Experimental | Other: Standard care, Device: Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)Patients randomized to this arm will receive standard care + pleuropulmonary ultrasound. Intervention: Standard care + ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patient consulting in the emergency department for dyspnea
Key exclusion criteria (7 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Standard careStandard care for dyspneic patients including contextual analysis, conventional clinical exam and a chest X-Ray. | Other | Standard care, Standard care + ultrasound |
| Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)Standard care (as described for the other intervention) + pleuropulmonary ultrasound using the Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI). | Device | Standard care + ultrasound |
Primary outcome
Length of hospital stay in days
Time frame: 1 month
49 secondary outcomes
Patient deceased? yes/no
Time frame: 1 month
Diagnosis in the emergency room
Time frame: upon discharge from the emergency department (max 1 month)
Diagnosis given by expert committee based on patient file
Time frame: 1 month
Glasgow scale
Time frame: Baseline, day 0
Glasgow scale
Time frame: day 3
Heart rate
Time frame: baseline, day 0
Heart rate
Time frame: day 3
Respiratory rate
Time frame: baseline, day 0
Respiratory rate
Time frame: day 3
Systolic blood pressure
Time frame: baseline, day 0
Systolic blood pressure
Time frame: day 3
Diastolic blood pressure
Time frame: baseline, day 0
Diastolic blood pressure
Time frame: day 3
Temperature
Time frame: baseline, day 0
Temperature
Time frame: day 3
blood pH
Time frame: baseline, day 0
blood pH
Time frame: day 3
CO2 arterial pressure
Time frame: baseline, day 0
CO2 arterial pressure
Time frame: day 3
O2 arterial pressure
Time frame: baseline, day 0
O2 arterial pressure
Time frame: day 3
O2 saturation
Time frame: baseline, day 0
O2 saturation
Time frame: day 3
Alkaline reserve
Time frame: baseline, day 0
Alkaline reserve
Time frame: day 3
white blood cell count
Time frame: baseline, day 0
white blood cell count
Time frame: day 3
C-reactive protein
Time frame: baseline, day 0
C-reactive protein
Time frame: day 3
Brain Natriuretic Peptide
Time frame: baseline, day 0
Brain Natriuretic Peptide
Time frame: day 3
hemoglobin
Time frame: baseline, day 0
hemoglobin
Time frame: day 3
Pulmonary x-ray, yes/no
Time frame: baseline, day 0
right alveolar opacities on x-ray, yes/no
Time frame: baseline, day 0
left alveolar opacities on x-ray, yes/no
Time frame: baseline, day 0
right parenchymal origin on x-ray, yes/no
Time frame: baseline, day 0
left parenchymal origin on x-ray, yes/no
Time frame: baseline, day 0
right pleural effusion on x-ray, yes/no
Time frame: baseline, day 0
left pleural effusion on x-ray, yes/no
Time frame: baseline, day 0
Results and safety
The study was stopped early (reason given: Inclusion curve too slow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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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.
Xavier Bobbia, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI) in people with Dyspnea, run by Centre Hospitalier Universitaire de Nīmes 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 7 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: stopped early, as of the sponsor's last update on 6 Apr 2016. 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 was stopped early (reason given: Inclusion curve too slow.). Results are not available in the source record.
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?
Length of hospital stay in days (time frame: 1 month). 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 6 Apr 2016.