An interventional study of Respironics Synchrony ventilator (Non Invasive Ventilation) in Chronic Obstructive Pulmonary Disease, sponsored by Philips Respironics. Completed at 1 site in United Kingdom. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-18.
Sponsored by Philips Respironics · Not applicable, Interventional, and Treatment
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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This study's enrollment of 22 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Exclusion Criteria
Non Invasive Ventilation using forced oscillation technique (FOT)
Device: Respironics Synchrony ventilator (Non Invasive Ventilation)
Non Invasive Ventilation using forced oscillation technique (FOT)
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 hours
Participants were recruited and screened with spirometry and determination of expiratory flow limitation prior to being enrolled into the study.
| Milestone | Therapy Arm |
|---|---|
| Started | 22 |
| Completed | 13 |
| Not completed | 9 |
| Withdrew: Adverse event | 2 |
| Withdrew: Withdrawal by subject | 7 |
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.
| cmH2O*s/L | Therapy Arm |
|---|---|
| Detection of Expiratory Flow Limitation | 2.6 (2 to 3) |
Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator.
| Participants | Therapy Arm |
|---|---|
| Flow limited | 8 |
| Not Flow Limited | 5 |
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.
| breaths | Therapy Arm |
|---|---|
| Flow limited | 534 |
| Not Flow Limited | 567 |
| Indeterminate | 1396 |
Collected over Over course of the study which was 3 months in duration.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Therapy Arm | 2/22 (9.1%) | 0/22 (0%) | 2/22 (9.1%) |
| Event | Therapy Arm |
|---|---|
| Chronic Obstructive Pulmonary Disease ExacerbationRespiratory, thoracic and mediastinal disorders | 2/22 |
| Age, Categorical(Participants) | Therapy Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 12 |
| Age, Continuous(years) | Therapy Arm |
|---|---|
| Mean | 67 ± 7.0 |
| Sex: Female, Male(Participants) | Therapy Arm |
|---|---|
| Female | 7 |
| Male | 15 |
| Region of Enrollment(participants) | Therapy Arm |
|---|---|
| United Kingdom | 22 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Philips Respironics