DyspneaNCT01206621
Vibration Response Imaging (VRI) in Dyspnea Patients Presenting to the ED
An observational study of Dyspnea, run by Deep Breeze at 8 sites in 2 countries.
Trial summary
For the patient with acute dyspnea in the ED, early differentiation between CHF and non-CHF causes is essential for proper management. The capacity to triage patients quickly and accurately has a beneficial impact upon outcome, disposition, stratification and length of stay in the ED and required length of hospital… Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Dyspnea
- How many people
- 530 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Aug 2010to Jun 2011
- 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 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the ED with acute dyspnea who are greater than 40 years of age and consisting of both male and females
Who may be able to join
- Able and willing to provide Informed Consent;
- ->40 years of age;
- Estimated Body Mass Index >19;
- Patient presented to the emergency department with a chief complaint of acute dyspnea.
Who cannot join
- Patients with obvious trauma or acute anxiety as a cause of dyspnea;
- Patient has already received directed therapy in the ED and symptoms are remarkably improved;
- Physician concern regarding possible harm to patient caused by positioning or ambulating the patient for VRI testing;
- Intubated or mechanically ventilated;
- Acute hemodynamic or ventilator instability requiring immediate resuscitation;
- Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture);
- Hirsutism.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Metrohealth Medical Center
Cleveland, Ohio, 44122
Julie Nichols, RN, 216-957-6488, jnichols@metrohealth.org
Rita Cydulka, MD
- Not yet recruiting
Baylor College of Medicine
Houston, Texas, 77030
Syed S Ali, MD, 713-873-8555, syeda@bcm.tmc.edu
Syed S Ali, MD
- Not yet recruiting
University of Nevada School of Medicine
Las Vegas, Nevada, 89106
David E Slattery, MD, 702-383-7885 ext. 5, dslatts@mac.com
David E Slattery, MD
- Recruiting
Mount Sinai School of Medicine
New York, New York, 10029
Janice Lam, 212-824-8078, Janice.Lam@mountsinai.org
Denise Nassisi, MD
- Recruiting
Christiana Care Health System
Newark, Delaware, 19718
Barbara Davis, RN, BSN, 302-733-4189, bdavis@christianacare.org.org
Jason T. Nomura, MD
- Recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Charles Pollack, 215-829-7549, cvpollack@gmail.com
Charles V Pollack, MD
- Recruiting
Lincoln Medical and Mental Health Center
The Bronx, New York, 10451
Muhammad Waseem, MD, 718-579-6010, waseemm2001@hotmail.com
Muhammad Waseem, MD
Israel1 site, 1 recruiting
- Not yet recruiting
Beilinson Hospital, Rabin Medical Center
Petah Tikva, 49100
Zvi Rotenberg, Dr, 9723-937-7000, zrotenberg@clalit.org.il
Zvi Rotenberg, Dr
About this study
Official title: Assessment of the Utility of Vibration Response Imaging (VRI) in Evaluating Dyspnea Patients Presenting to the Emergency Department
For the patient with acute dyspnea in the ED, early differentiation between CHF and non-CHF causes is essential for proper management. The capacity to triage patients quickly and accurately has a beneficial impact upon outcome, disposition, stratification and length of stay in the ED and required length of hospital admission.
The ability to assess pulmonary status rapidly by quantitative regional vibration technology offers significant potential advantage for earlier diagnosis. The VRI technique may provide a quick and accurate method of differentiating between dyspnea due to HF and dyspnea due to pulmonary causes; thereby improving management and outcomes.
- Conditions
- Dyspnea
- Keywords
- dyspnea, COPD, CHF, asthma
- Medical subject headings
- Dyspnea, Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ED patients presenting with dyspnea | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the ability of the VRI to improve clinical outcomes via accurate, early classification of the cause of acute dyspnea as HF or other (i.e. COPD, PE etc).
The primary efficacy analysis set (PEAS) consists of all patients who have Gold Standard (GS) diagnosis (CHF/non-CHF) \& VRI records.
- Accuracy rate is defined as the accuracy between the GS and VRI.
- Accuracy parameters between the GS and VRI will be calculated using accuracy rate, sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV) \& likelihood ratios (+,-).
Measured: Baseline testing at ED presentation
Secondary outcomes (3)
Assess the agreement to aid in classifying the cause of acute dyspnea as HF or other of the VRI in comparison to BNP/NTproBNP assays.
The secondary efficacy analysis set (SEAS) consists of all patients who have final diagnosis (CHF/non-CHF), BNP/NT-proBNP \& VRI results.
- Agreement rate (2X2 agreement table) between BNP/NT-proBNP (based on separate decision cut-offs for each assay) and VRI will be calculated for dyspnea due to CHF or other causes.
- The discordant observations (from the agreement table) will be further evaluated between the VRI and GS.
- Logistic regression will be used in order to find the significance and strength contribution of the VRI and the BNP on the goal-function.
Measured: Baseline testing at ED presentation
Assess the ability of the VRI to aid in classifying the cause of acute dyspnea as HF or COPD
The tertiary efficacy analysis set (TEAS) consists of all patients who have final diagnosis (CHF/COPD) \& VRI results.
-Similar to the previous objectives - accuracy (with the GS) and agreement rates (with BNP/NT-proBNP); comparisons based only on CHF and COPD patients.
Measured: Baseline testing at ED presentation
Evaluate the ability of the VRI to monitor changes in clinical status following treatment in comparison with other standard testing methods (e.g. ECG, serial chest x-rays, etc.)
The fourth efficacy analysis set consists of patients who have baseline \& after treatment follow-up clinical data \& VRI recordings.
- Descriptive statistics will be used in order to evaluate the changes following treatment in comparison to baseline condition.
- The changes will be categorized to status of improved, worse or same and will be compared, when available, to existing tools.
Measured: Baseline testing and repeated testing after 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
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 DyspneaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deep Breeze
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charles V. Pollack, MD, Principal investigator, Pennsylvania Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206621
- Sponsor's protocol ID
- DB051
- Status last verified
- Sep 2010
- First submitted
- 21 Sep 2010
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang Z, Bartter T, Baumann BM, Abouzgheib W, Chansky ME, Jean S. Asynchrony between left and right lungs in acute asthma. J Asthma. 2008 Sep;45(7):575-8. doi: 10.1080/02770900802017744.
PubMed 18773329Guntupalli KK, Reddy RM, Loutfi RH, Alapat PM, Bandi VD, Hanania NA. Evaluation of obstructive lung disease with vibration response imaging. J Asthma. 2008 Dec;45(10):923-30. doi: 10.1080/02770900802395496.
PubMed 19085584Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.
PubMed 17551264
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Utility of Vibration Response Imaging (VRI) in Evaluating Dyspnea Patients Presenting to the Emergency Department
- ClinicalTrials.gov ID
- NCT01206621
- Acronym / sponsor ID
- DB051
- Conditions
- Dyspnea
- Keywords
- dyspnea, COPD, CHF, asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Deep BreezeIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 22 Sep 2010 (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.
For the patient with acute dyspnea in the ED, early differentiation between CHF and non-CHF causes is essential for proper management. The capacity to triage patients quickly and accurately has a beneficial impact upon outcome, disposition, stratification and length of stay in the ED and required length of hospital admission.
The ability to assess pulmonary status rapidly by quantitative regional vibration technology offers significant potential advantage for earlier diagnosis. The VRI technique may provide a quick and accurate method of differentiating between dyspnea due to HF and dyspnea due to pulmonary causes; thereby improving management and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED patients presenting with dyspnea | – | – |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the ED with acute dyspnea who are greater than 40 years of age and consisting of both male and females
Key inclusion criteria (4 listed)
- Able and willing to provide Informed Consent;
- ->40 years of age;
- Estimated Body Mass Index >19;
- Patient presented to the emergency department with a chief complaint of acute dyspnea.
Key exclusion criteria (7 listed)
- Patients with obvious trauma or acute anxiety as a cause of dyspnea;
- Patient has already received directed therapy in the ED and symptoms are remarkably improved;
- Physician concern regarding possible harm to patient caused by positioning or ambulating the patient for VRI testing;
- Intubated or mechanically ventilated;
- Acute hemodynamic or ventilator instability requiring immediate resuscitation;
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
Assess the ability of the VRI to improve clinical outcomes via accurate, early classification of the cause of acute dyspnea as HF or other (i.e. COPD, PE etc).
Time frame: Baseline testing at ED presentation
The primary efficacy analysis set (PEAS) consists of all patients who have Gold Standard (GS) diagnosis (CHF/non-CHF) \& VRI records. * Accuracy rate is defined as the accuracy between the GS and VRI. * Accuracy parameters between the GS and VRI will be calculated using accuracy rate, sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV) \& likelihood ratios (+,-).
3 secondary outcomes
Assess the agreement to aid in classifying the cause of acute dyspnea as HF or other of the VRI in comparison to BNP/NTproBNP assays.
Time frame: Baseline testing at ED presentation
Assess the ability of the VRI to aid in classifying the cause of acute dyspnea as HF or COPD
Time frame: Baseline testing at ED presentation
Evaluate the ability of the VRI to monitor changes in clinical status following treatment in comparison with other standard testing methods (e.g. ECG, serial chest x-rays, etc.)
Time frame: Baseline testing and repeated testing after 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2011.
- Background: PubMed 18773329Wang Z, Bartter T, Baumann BM, Abouzgheib W, Chansky ME, Jean S. Asynchrony between left and right lungs in acute asthma. J Asthma. 2008 Sep;45(7):575-8. doi: 10.1080/02770900802017744.
- Background: PubMed 19085584Guntupalli KK, Reddy RM, Loutfi RH, Alapat PM, Bandi VD, Hanania NA. Evaluation of obstructive lung disease with vibration response imaging. J Asthma. 2008 Dec;45(10):923-30. doi: 10.1080/02770900802395496.
- Background: PubMed 17551264Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.
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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.
Charles V. Pollack, MD principal investigator
Pennsylvania Hospital
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, run by Deep Breeze at 8 sites in 2 countries.
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 4 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: status not confirmed, as of the sponsor's last update on 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles V. Pollack, MD (215-829-7549, cvpollack@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the ability of the VRI to improve clinical outcomes via accurate, early classification of the cause of acute dyspnea as HF or other (i.e. COPD, PE etc). (time frame: Baseline testing at ED presentation). 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 NCT01206621, 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 13 May 2011.