AsthmaNCT01414322
Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients
An observational study of Asthma and Bronchiolitis, run by KarmelSonix Ltd. at 1 site in Israel.
Trial summary
Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Asthma, Bronchiolitis
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2011to Sep 2012
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric emergency room patients ages 0 - 15 with shortness of breath upon arrival at the hospital
Who may be able to join
- patient is admitted to the ER with shortness of breath
- patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including:
- asthma management protocol
- bronchiolitis management protocol
- ages 0 - 15
- patient's parent/guardian is able to comprehend and give informed consent for participating in the study
Who cannot join
- patient has received any dose of inhaled bronchodilators in the hour prior to enrollment
- patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment
- ventilated patients, while ventilated
- chest skin lesions
- cystic fibrosis
- hemodynamic instability
Show all 9Show fewer
- patient's parent/guardian objects to the study protocol
- concurrent participation in any other clinical study
- physician objection
Trial locations and contacts
1 site in 1 country.
About this study
Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.
- Conditions
- Asthma, Bronchiolitis
- Medical subject headings
- Asthma, Bronchiolitis
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 |
|---|---|---|
| Group 1: Patients ages 0 - 3 | Not described | |
| Group 2: Patients ages 3 - 7 | Not described | |
| Group 3: Patients ages 7 - 15 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase or decrease of WheezeRate (the proportion of wheezing in the respiratory cycle)
Characterize the dynamic pattern of wheeze rate (increase or decrease by 50% or unchanged) within 30 minutes of onset of therapy, and to correlate pattern to clinical diagnoses, severity assessment (accessory muscle use, oxygen saturation, inspiratory/expiratory ratio, severity of wheezing), and outcome (admission versus discharge).
Measured: Duration (from beginning to end) of emergency department stay. On average, 3 hours.
Secondary outcomes (1)
cough count (increase or decrease by more then 1 cough event or unchanged) in response to treatment
cough count (increase or decrease by more then 1 cough event or unchanged) in response to treatment and to correlate pattern to clinical diagnoses, severity assessment (accessory muscle use, oxygen saturation, inspiratory/expiratory ratio, severity of wheezing), and outcome (admission versus discharge).
Measured: Duration (from beginning to end) of emergency department stay. On average, 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KarmelSonix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Investigators
- Eitan Kerem, Prof., Principal investigator, Hadassah Medical Center Mt. Scopus, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414322
- Sponsor's protocol ID
- KSI-IL-HHZ-ER-01
- Status last verified
- Aug 2011
- First submitted
- 2 Aug 2011
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients
- ClinicalTrials.gov ID
- NCT01414322
- Acronym / sponsor ID
- KSI-IL-HHZ-ER-01
- Conditions
- Asthma, Bronchiolitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- KarmelSonix Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 11 Aug 2011 (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.
Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients ages 0 - 3 | – | – |
| Group 2: Patients ages 3 - 7 | – | – |
| Group 3: Patients ages 7 - 15 | – | – |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric emergency room patients ages 0 - 15 with shortness of breath upon arrival at the hospital
Key inclusion criteria (6 listed)
- patient is admitted to the ER with shortness of breath
- patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including:
- ages 0 - 15
- patient's parent/guardian is able to comprehend and give informed consent for participating in the study
Key exclusion criteria (9 listed)
- patient has received any dose of inhaled bronchodilators in the hour prior to enrollment
- patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment
- ventilated patients, while ventilated
- chest skin lesions
- cystic fibrosis
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
increase or decrease of WheezeRate (the proportion of wheezing in the respiratory cycle)
Time frame: Duration (from beginning to end) of emergency department stay. On average, 3 hours.
Characterize the dynamic pattern of wheeze rate (increase or decrease by 50% or unchanged) within 30 minutes of onset of therapy, and to correlate pattern to clinical diagnoses, severity assessment (accessory muscle use, oxygen saturation, inspiratory/expiratory ratio, severity of wheezing), and outcome (admission versus discharge).
1 secondary outcome
cough count (increase or decrease by more then 1 cough event or unchanged) in response to treatment
Time frame: Duration (from beginning to end) of emergency department stay. On average, 3 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
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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.
Eitan Kerem, Prof. principal investigator
Hadassah Medical Center Mt. Scopus, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Bronchiolitis, run by KarmelSonix Ltd. at 1 site in Israel.
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 6 inclusion and 9 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 11 Aug 2011. 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 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 Noam Gavriely, MD PhD (+972 54 466 1337, noam@karmelsonix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase or decrease of WheezeRate (the proportion of wheezing in the respiratory cycle) (time frame: Duration (from beginning to end) of emergency department stay. On average, 3 hours.). 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 11 Aug 2011.