Airway Secretion ClearanceNCT00717873
Evaluation of High-Frequency Chest Wall Oscillation
A study testing Airway clearance Device in people with Airway Secretion Clearance, run by Hill-Rom at 1 site in United States.
Trial summary
To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Secretion Clearance
- What is being tested?
- Airway clearance Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute or chronic disease requiring secretion mobilization as per hospital protocol
Who cannot join
- Absolute contraindications for positional changes
- Absolute contraindications for chest percussion
- Women visibly pregnant
- Previous enrollment in study
- Previous CPT or Vest treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy
- Conditions
- Airway Secretion Clearance
- Being tested
- Airway clearance Device
- Keywords
- Mucus Clearance, Secretion Clearance, HFCWO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway clearance DeviceDevice
Provided by the Vest Airway clearance system
| Study group | Role | What they receive |
|---|---|---|
| HFCWO Arm | Experimental | Airway clearance provided by the Vest Airway Clearance System Receives: Device: Airway clearance Device |
| CPT Arm | No intervention | Airway clearance provided by manual CPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
an average of 10 days
Measured: Admission to Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionDec 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Airway Secretion ClearanceStudies 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
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darnetta Clinkscale, RRT, Principal investigator, Barnes-Jewish Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717873
- Sponsor's protocol ID
- CR-0080
- Status last verified
- Jul 2017
- First submitted
- 1 Jul 2008
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Morrison L, Milroy S. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Apr 30;4(4):CD006842. doi: 10.1002/14651858.CD006842.pub5.
PubMed 32352564Clinkscale D, Spihlman K, Watts P, Rosenbluth D, Kollef MH. A randomized trial of conventional chest physical therapy versus high frequency chest wall compressions in intubated and non-intubated adults. Respir Care. 2012 Feb;57(2):221-8. doi: 10.4187/respcare.01299. Epub 2011 Jul 12.
PubMed 21762564
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
- Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
- ClinicalTrials.gov ID
- NCT00717873
- Acronym / sponsor ID
- CR-0080
- Conditions
- Airway Secretion Clearance
- Keywords
- Mucus Clearance, Secretion Clearance, HFCWO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Posted 25 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFCWO Arm | Experimental | Device: Airway clearance DeviceAirway clearance provided by the Vest Airway Clearance System |
| CPT Arm | No intervention | –Airway clearance provided by manual CPT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute or chronic disease requiring secretion mobilization as per hospital protocol
Key exclusion criteria (5 listed)
- Absolute contraindications for positional changes
- Absolute contraindications for chest percussion
- Women visibly pregnant
- Previous enrollment in study
- Previous CPT or Vest treatment
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 |
|---|---|---|
| Airway clearance DeviceProvided by the Vest Airway clearance system | Device | HFCWO Arm |
Primary outcome
Hospital Length of Stay
Time frame: Admission to Discharge
an average of 10 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.
- Derived from this study: PubMed 32352564Morrison L, Milroy S. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Apr 30;4(4):CD006842. doi: 10.1002/14651858.CD006842.pub5.
- Derived from this study: PubMed 21762564Clinkscale D, Spihlman K, Watts P, Rosenbluth D, Kollef MH. A randomized trial of conventional chest physical therapy versus high frequency chest wall compressions in intubated and non-intubated adults. Respir Care. 2012 Feb;57(2):221-8. doi: 10.4187/respcare.01299. Epub 2011 Jul 12.
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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.
Darnetta Clinkscale, RRT principal investigator
Barnes-Jewish Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway clearance Device in people with Airway Secretion Clearance, run by Hill-Rom at 1 site 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 5 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 1 site 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 25 Sep 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?
Hospital Length of Stay (time frame: Admission to Discharge). 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 NCT00717873, which also lists 2 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 7 Aug 2017.