PneumoniaNCT00992966
Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms
An observational study of Pneumonia, run by Deep Breeze.
Trial summary
The VRI device may provide a complementary diagnostic tool for lung examination and aid the physician in determining whether a chest x-ray should be performed. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pneumonia
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A total number of 80 patients in the age range of 3-18 and consisting of both boys and girls, preferably in an equal distribution
Who may be able to join
- Subject's parent or legal guardian, is able and willing to read the Informed Consent, understands the Informed Consent, and provides written Informed Consent for the subject; if the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.
- Boy or girl in the age range of 3-18 years.
- Patient presented with acute respiratory complaints, acute cough, onset of shortness of breath, or fever.
- Patient referred by ED physician and presented for CXR.
Who cannot join
- 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);
- Potentially contagious skin lesion on the back;
- Subject has had lung surgery;
- Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms.
About this study
Official title: Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms.
The VRI device may provide a complementary diagnostic tool for lung examination and aid the physician in determining whether a chest x-ray should be performed.
Read the detailed description
This study is a prospective, single center study to determine the value of VRI images as an aid in determining whether a chest x ray is necessary to evaluate children presenting with acute respiratory complaints.
Study participants will be children, selected from the Emergency Department (ED), who were designated to undergo a PA and Left Lateral CXR because of acute respiratory complaints such as a new respiratory condition, acute cough, onset of shortness of breath, or fever.
Patients who meet the study inclusion and exclusion criteria will be enrolled and will be recorded by the VRI device.
A technician will perform a CXR on the enrolled patients. The CXR and the VRI will be performed on the same day within 6 hours of each other.
VRI readers, who are blinded to the patient's CXR, history, and physical exam, will evaluate the VRI recording. The VRI reader will review the VRI images and, using the lexicon of images supplied by Deep Breeze, determine whether the VRI is normal or abnormal.
Certified radiologists will review the patient's CXR and will determine whether the CXR is normal or abnormal based solely on the CXR.
The VRI readers determination of normal or abnormal for each subject will be compared to the radiologists determination of normal or abnormal CXR for each subject.
- Conditions
- Pneumonia
- Keywords
- to acquire database of pneumonia cases in children
- Medical subject headings
- Pneumonia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
Why it stopped: Study initiation has been delayed due to Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deep Breeze
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Liora Kornreich, M.D, Principal investigator, Shnider medical centerLiora Kornreich, Professor, Principal investigator, Shnider medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992966
- Sponsor's protocol ID
- DB048
- Status last verified
- Aug 2010
- First submitted
- 8 Oct 2009
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms.
- ClinicalTrials.gov ID
- NCT00992966
- Acronym / sponsor ID
- DB048
- Conditions
- Pneumonia
- Keywords
- to acquire database of pneumonia cases in children
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study initiation has been delayed due to Sponsor decision
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Deep BreezeIndustry (pharma, biotech, devices)
- First posted
- 9 Oct 2009 (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 VRI device may provide a complementary diagnostic tool for lung examination and aid the physician in determining whether a chest x-ray should be performed.
Detailed description
This study is a prospective, single center study to determine the value of VRI images as an aid in determining whether a chest x ray is necessary to evaluate children presenting with acute respiratory complaints.
Study participants will be children, selected from the Emergency Department (ED), who were designated to undergo a PA and Left Lateral CXR because of acute respiratory complaints such as a new respiratory condition, acute cough, onset of shortness of breath, or fever.
Patients who meet the study inclusion and exclusion criteria will be enrolled and will be recorded by the VRI device.
A technician will perform a CXR on the enrolled patients. The CXR and the VRI will be performed on the same day within 6 hours of each other.
VRI readers, who are blinded to the patient's CXR, history, and physical exam, will evaluate the VRI recording. The VRI reader will review the VRI images and, using the lexicon of images supplied by Deep Breeze, determine whether the VRI is normal or abnormal.
Certified radiologists will review the patient's CXR and will determine whether the CXR is normal or abnormal based solely on the CXR.
The VRI readers determination of normal or abnormal for each subject will be compared to the radiologists determination of normal or abnormal CXR for each subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A total number of 80 patients in the age range of 3-18 and consisting of both boys and girls, preferably in an equal distribution
Key inclusion criteria (4 listed)
- Subject's parent or legal guardian, is able and willing to read the Informed Consent, understands the Informed Consent, and provides written Informed Consent for the subject; if the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.
- Boy or girl in the age range of 3-18 years.
- Patient presented with acute respiratory complaints, acute cough, onset of shortness of breath, or fever.
- Patient referred by ED physician and presented for CXR.
Key exclusion criteria (4 listed)
- 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);
- Potentially contagious skin lesion on the back;
- Subject has had lung surgery;
- Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2010.
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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.
Liora Kornreich, M.D principal investigator
Shnider medical center
Liora Kornreich, Professor principal investigator
Shnider medical center
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Deep Breeze.
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 4 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: paused, as of the sponsor's last update on 20 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 20 Aug 2010.