- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01151618
Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation
Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation in Patients With Stable Chronic Pulmonary Disease (COPD)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Liverpool, United Kingdom, L97AL
- University Hospital Aintree
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Respironics Synchrony ventilator (Non Invasive Ventilation)
Non Invasive Ventilation using forced oscillation technique (FOT)
|
Non Invasive Ventilation using forced oscillation technique (FOT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
within 2 hours
|
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.
|
2 hours
|
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.
|
2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Calverley, Professor, Aintree University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRC-1018-FOTVal-SS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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