Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation in Patients With Stable Chronic Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Respironics Synchrony ventilator (Non Invasive Ventilation)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respironics Synchrony ventilator (Non Invasive Ventilation)<br>Non Invasive Ventilation using forced oscillation technique (FOT) | Device: Respironics Synchrony ventilator (Non Invasive Ventilation)<br>* Non Invasive Ventilation using forced oscillation technique (FOT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD