Chronic Obstructive Pulmonary DiseaseNCT01151618
Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation
A study testing Respironics Synchrony ventilator (Non Invasive Ventilation) in people with Chronic Obstructive Pulmonary Disease, run by Philips Respironics at 1 site in United Kingdom.
Trial summary
To validate the capability of the Respironics Synchrony ventilator to properly detect Expiratory Flow Limitation (EFL) as compared to the gold standard method of detecting EFL via the Mead and Wittenberger technique. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Respironics Synchrony ventilator (Non Invasive Ventilation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Sep 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age < 80 years
- Moderate - Severe COPD diagnosed by spirometry (according to the GOLD criteria - Global Initiative for Chronic Obstructive Lung Disease criteria)
- Free from any exacerbation in the 6 weeks preceding the study
Who cannot join
- Any co-existing cardio-pulmonary conditions which may result in a picture of ventilatory failure such as congestive cardiac failure, chest wall or neuromuscular disease, bronchopneumonia, pulmonary fibrosis, bronchiectasis, cystic fibrosis or obesity-hypoventilation syndrome
- Clinically unstable; exacerbation within the preceding 6 weeks
- The presence of pulmonary or extra-pulmonary neoplasia that is still active
- The presence of a bleeding diathesis
- Unstable coronary artery disease
- Presence of tuberculosis, current infection or potentially infectious pathogen
- Inability to provide informed consent to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation in Patients With Stable Chronic Pulmonary Disease (COPD)
To validate the capability of the Respironics Synchrony ventilator to properly detect Expiratory Flow Limitation (EFL) as compared to the gold standard method of detecting EFL via the Mead and Wittenberger technique.
Read the detailed description
Positive end expiratory pressure (PEEP) is used in COPD patients to counteract the intrinsic PEEP (PEEPi), which represents the end expiratory recoil pressure of the total respiratory system due to the presence of dynamic hyperinflation (DH).
DH commonly occurs in COPD, where the presence of expiratory flow-limitation (EFL) requires the patient to breath at higher lung volumes to produce the necessary after appropriate leak correction, showed a sensitivity and specificity in detecting EFL expiratory flow. To be effective, the PEEP level applied to the patient should be equal to PEEPi.
The continuous monitoring of EFL could be a useful tool to select the minimum PEEP level required to abolish it.
EFL can be detected using the forced oscillation technique (FOT) by an index which quantifies, for each breath, the within-breath variations of respiratory reactance (delta Xrs) at 5Hz.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Respironics Synchrony ventilator (Non Invasive Ventilation)
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respironics Synchrony ventilator (Non Invasive Ventilation)Device
Non Invasive Ventilation using forced oscillation technique (FOT)
| Study group | Role | What they receive |
|---|---|---|
| Respironics Synchrony ventilator (Non Invasive Ventilation) | Experimental | Non Invasive Ventilation using forced oscillation technique (FOT) Receives: Device: Respironics Synchrony ventilator (Non Invasive Ventilation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Expiratory Flow Limitation
Expiratory flow limitation (EFL) is an increase in transpulmonary pressure (cmH2O) with no change expiratory flow (lpm).
Expiratory Flow Limitation or absence thereof will be detected by using a measurement of changes in reactance (DeltaXrs - cmH2O*s/L) it will be compared to the the Mead and Whittenberger technique (via esophageal balloon measuring transpulmonary pressures).
Two measurements will be obtained, DeltaXrs and Transpulmonary pressure. Comparisons of these measurements will be made to determine if the participant exhibits EFL.
Measured: within 2 hours
Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator
Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator.
Measured: 2 hours
Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique
Number of breaths are cumulative across all participants were found to be flow limited, not-flow limited or indeterminate as determined by the Mead and Wittenberger (M-W) technique of esophageal pressure. Each participant's individual breaths was imported into Matlab software program that displayed the flow vs transpleural pressure and breaths were individually analyzed according to the Mead Wittenberger technique.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionSep 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 Chronic Obstructive Pulmonary DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Calverley, Professor, Principal investigator, Aintree University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151618
- Sponsor's protocol ID
- HRC-1018-FOTVal-SS
- Status last verified
- Mar 2019
- First submitted
- 21 Jun 2010
- Last updated
- 18 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation in Patients With Stable Chronic Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01151618
- Acronym / sponsor ID
- HRC-1018-FOTVal-SS
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Posted 18 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To validate the capability of the Respironics Synchrony ventilator to properly detect Expiratory Flow Limitation (EFL) as compared to the gold standard method of detecting EFL via the Mead and Wittenberger technique.
Detailed description
Positive end expiratory pressure (PEEP) is used in COPD patients to counteract the intrinsic PEEP (PEEPi), which represents the end expiratory recoil pressure of the total respiratory system due to the presence of dynamic hyperinflation (DH).
DH commonly occurs in COPD, where the presence of expiratory flow-limitation (EFL) requires the patient to breath at higher lung volumes to produce the necessary after appropriate leak correction, showed a sensitivity and specificity in detecting EFL expiratory flow. To be effective, the PEEP level applied to the patient should be equal to PEEPi.
The continuous monitoring of EFL could be a useful tool to select the minimum PEEP level required to abolish it.
EFL can be detected using the forced oscillation technique (FOT) by an index which quantifies, for each breath, the within-breath variations of respiratory reactance (delta Xrs) at 5Hz.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respironics Synchrony ventilator (Non Invasive Ventilation) | Experimental | Device: Respironics Synchrony ventilator (Non Invasive Ventilation)Non Invasive Ventilation using forced oscillation technique (FOT) |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age < 80 years
- Moderate - Severe COPD diagnosed by spirometry (according to the GOLD criteria - Global Initiative for Chronic Obstructive Lung Disease criteria)
- Free from any exacerbation in the 6 weeks preceding the study
Key exclusion criteria (7 listed)
- Any co-existing cardio-pulmonary conditions which may result in a picture of ventilatory failure such as congestive cardiac failure, chest wall or neuromuscular disease, bronchopneumonia, pulmonary fibrosis, bronchiectasis, cystic fibrosis or obesity-hypoventilation syndrome
- Clinically unstable; exacerbation within the preceding 6 weeks
- The presence of pulmonary or extra-pulmonary neoplasia that is still active
- The presence of a bleeding diathesis
- Unstable coronary artery disease
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 |
|---|---|---|
| Respironics Synchrony ventilator (Non Invasive Ventilation)Non Invasive Ventilation using forced oscillation technique (FOT) | Device | Respironics Synchrony ventilator (Non Invasive Ventilation) |
Primary outcome
Detection of Expiratory Flow Limitation
Time frame: within 2 hours
Expiratory flow limitation (EFL) is an increase in transpulmonary pressure (cmH2O) with no change expiratory flow (lpm). Expiratory Flow Limitation or absence thereof will be detected by using a measurement of changes in reactance (DeltaXrs - cmH2O*s/L) it will be compared to the the Mead and Whittenberger technique (via esophageal balloon measuring transpulmonary pressures). Two measurements will be obtained, DeltaXrs and Transpulmonary pressure. Comparisons of these measurements will be made to determine if the participant exhibits EFL.
Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator
Time frame: 2 hours
Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator.
Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique
Time frame: 2 hours
Number of breaths are cumulative across all participants were found to be flow limited, not-flow limited or indeterminate as determined by the Mead and Wittenberger (M-W) technique of esophageal pressure. Each participant's individual breaths was imported into Matlab software program that displayed the flow vs transpleural pressure and breaths were individually analyzed according to the Mead Wittenberger technique.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- 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.
Peter Calverley, Professor principal investigator
Aintree University 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 Respironics Synchrony ventilator (Non Invasive Ventilation) in people with Chronic Obstructive Pulmonary Disease, run by Philips Respironics at 1 site in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 18 Mar 2019. 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 Kingdom. 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 18 Mar 2019). 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?
Detection of Expiratory Flow Limitation (time frame: within 2 hours). The study lists 3 primary outcomes in all. 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 18 Mar 2019.