Bronchial AsthmaNCT00722020
HFCWO in Hospitalized Asthmatic Children
A study testing VEST in people with Bronchial Asthma and Asthma, run by Hill-Rom at 2 sites in United States.
Trial summary
To determine whether or not high frequency chest wall oscillation (in the form of the VestTM) is superior to regular asthma therapy in the management of children hospitalized with moderate to severe asthma. Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Bronchial Asthma, Asthma, Status Asthmaticus
- What is being tested?
- VEST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any pediatric patient between the ages of 18 months and 18 years admitted to Winthrop University Hospital's pediatric floor or intensive care unit with a diagnosis of asthma or reactive airway disease
Who cannot join
- Patients with chronic, comorbid respiratory conditions (e.g., cerebral palsy, cystic fibrosis)
- Those who regularly use HFCWO
- Any patient exhibiting an absolute contraindication to HFCWO therapy
- Absolute contraindications to using HFCWO include head and neck injury prior to stabilization, and active hemorrhage with hemodynamic instability
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Winthrop University Hospital, Winthrop Pediatric Associates
Long Island City, New York, 11501
Winthrop University Hospital
Long Island City, New York, 11501
About this study
Official title: High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children
To determine whether or not high frequency chest wall oscillation (in the form of the VestTM) is superior to regular asthma therapy in the management of children hospitalized with moderate to severe asthma.
Read the detailed description
A historically controlled pilot study was conducted in pediatric patients 18 months to 18 years of age hospitalized with a diagnosis of asthma or reactive airway disease and admitted to the pediatric intensive care unit. Upon receiving informed consent, patients were treated with HFCWO therapy via the VEST. The primary endpoint was time to readiness for discharge, lack of need for continued supportive care (e.g., intravenous fluid or oxygen), and bronchodilator treatments spaced at least four hours apart.
- Conditions
- Bronchial Asthma, Asthma, Status Asthmaticus
- Being tested
- VEST
- Keywords
- Asthma, Bronchial Disease, Status Asthmaticus, High Frequency Chest Wall Oscillation, the Vest, HFCWO
- Medical subject headings
- Asthma, Status Asthmaticus, Bronchial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VESTDevice
Also called Hill-Rom Vest(tm)
15 minutes of HFCWO via the Vest 2-3 times daily
| Study group | Role | What they receive |
|---|---|---|
| Vest Arm | Experimental | HFCWO treatments 2-3 times daily 15 minutes per treatment via the VEST Receives: Device: VEST |
| Control | No intervention | Historical control for PICU asthma patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint Will be Time to Readiness for Discharge.
Days in the hospital prior to patient being clinically ready to discharge
Measured: 30 days
Secondary outcomes (1)
Secondary Endpoint Total Hospital Length of Stay
Seconadary endpoint was Total Hospital length of stay
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bronchial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon Roberts, MD, Principal investigator, Winthrop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722020
- Sponsor's protocol ID
- CR-0078
- Status last verified
- Jul 2017
- First submitted
- 23 Jul 2008
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children
- ClinicalTrials.gov ID
- NCT00722020
- Acronym / sponsor ID
- CR-0078
- Conditions
- Bronchial Asthma, Asthma, Status Asthmaticus
- Keywords
- Asthma, Bronchial Disease, Status Asthmaticus, High Frequency Chest Wall Oscillation, the Vest, HFCWO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Jul 2008 (estimated)
- Results
- Posted 24 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether or not high frequency chest wall oscillation (in the form of the VestTM) is superior to regular asthma therapy in the management of children hospitalized with moderate to severe asthma.
Detailed description
A historically controlled pilot study was conducted in pediatric patients 18 months to 18 years of age hospitalized with a diagnosis of asthma or reactive airway disease and admitted to the pediatric intensive care unit. Upon receiving informed consent, patients were treated with HFCWO therapy via the VEST. The primary endpoint was time to readiness for discharge, lack of need for continued supportive care (e.g., intravenous fluid or oxygen), and bronchodilator treatments spaced at least four hours apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vest Arm | Experimental | Device: VESTHFCWO treatments 2-3 times daily 15 minutes per treatment via the VEST |
| Control | No intervention | –Historical control for PICU asthma patients |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Any pediatric patient between the ages of 18 months and 18 years admitted to Winthrop University Hospital's pediatric floor or intensive care unit with a diagnosis of asthma or reactive airway disease
Key exclusion criteria (4 listed)
- Patients with chronic, comorbid respiratory conditions (e.g., cerebral palsy, cystic fibrosis)
- Those who regularly use HFCWO
- Any patient exhibiting an absolute contraindication to HFCWO therapy
- Absolute contraindications to using HFCWO include head and neck injury prior to stabilization, and active hemorrhage with hemodynamic instability
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 |
|---|---|---|
| VESTAlso: Hill-Rom Vest(tm)15 minutes of HFCWO via the Vest 2-3 times daily | Device | Vest Arm |
Primary outcome
The Primary Endpoint Will be Time to Readiness for Discharge.
Time frame: 30 days
Days in the hospital prior to patient being clinically ready to discharge
1 secondary outcome
Secondary Endpoint Total Hospital Length of Stay
Time frame: 30 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jon Roberts, MD principal investigator
Winthrop University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VEST in people with Bronchial Asthma and Asthma, run by Hill-Rom at 2 sites in United States.
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 1 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: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 24 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Endpoint Will be Time to Readiness for Discharge. (time frame: 30 days). 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 7 Aug 2017.