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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respironics Synchrony ventilator (Non Invasive Ventilation) | Experimental | Non Invasive Ventilation using forced oscillation technique (FOT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respironics Synchrony ventilator (Non Invasive Ventilation) | Device | Non Invasive Ventilation using forced oscillation technique (FOT) |
|
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Peter Calverley, Professor | Aintree University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Aintree | Liverpool | L97AL | United Kingdom |
22 patient were recruited in June of 2010.
Participants were recruited and screened with spirometry and determination of expiratory flow limitation prior to being enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapy Arm | Non Invasive Ventilation using forced oscillation technique (FOT) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapy Arm | Non Invasive Ventilation using forced oscillation technique (FOT) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants that completed the protocol were analyzed. | Posted | Least Squares Mean | 90% Confidence Interval | cmH2O*s/L | within 2 hours |
|
Over course of the study which was 3 months in duration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Therapy Arm | Non Invasive Ventilation using forced oscillation technique (FOT) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease Exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | 2 participants had COPD exacerbations after consent but prior to study treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bob Romano, Biomedical Engineer | Philips Respironics | 724-387-7781 | bob.romano@philips.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | 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. | All participants that completed the protocol were analyzed. | Posted | Count of Participants | Participants | 2 hours |
|
|
|
| Primary | 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. | All participants that completed the protocol were analyzed. | Posted | Number | breaths | 2 hours |
|
|
|
| 2 |
| 22 |
| 0 |
| 22 |
| 2 |
| 22 |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|