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Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation

Not Applicable
Completed
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Device: Respironics Synchrony ventilator (Non Invasive Ventilation)
Registration Number
NCT01151618
Lead Sponsor
Philips Respironics
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
22
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Respironics Synchrony ventilator (Non Invasive Ventilation)Respironics Synchrony ventilator (Non Invasive Ventilation)Non Invasive Ventilation using forced oscillation technique (FOT)
Primary Outcome Measures
NameTimeMethod
Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique2 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.

Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator2 hours

Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator.

Detection of Expiratory Flow Limitationwithin 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University Hospital Aintree

🇬🇧

Liverpool, United Kingdom

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