Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
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.
Interventions
DEVICERespironics Synchrony ventilator (Non Invasive Ventilation)
Non Invasive Ventilation using forced oscillation technique (FOT)
Sponsors
Philips Respironics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age \< 80 years 2. Moderate - Severe COPD diagnosed by spirometry (according to the GOLD criteria - Global Initiative for Chronic Obstructive Lung Disease criteria) 3. Free from any exacerbation in the 6 weeks preceding the study
Exclusion criteria
1. 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 2. Clinically unstable; exacerbation within the preceding 6 weeks 3. The presence of pulmonary or extra-pulmonary neoplasia that is still active 4. The presence of a bleeding diathesis 5. Unstable coronary artery disease 6. Presence of tuberculosis, current infection or potentially infectious pathogen 7. Inability to provide informed consent to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Expiratory Flow Limitation | 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. |
| Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator | 2 hours | Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator. |
| Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited and screened with spirometry and determination of expiratory flow limitation prior to being enrolled into the study.
Pre-assignment details
22 patient were recruited in June of 2010. * 13 patients studied * (7 didn't tolerate balloon; 2 had an exacerbation )
Participants by arm
| Arm | Count |
|---|---|
| Therapy Arm Non Invasive Ventilation using forced oscillation technique (FOT) | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Therapy Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 7 |
| Region of Enrollment United Kingdom | 22 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 22 |
| other Total, other adverse events | 2 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
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.
Time frame: within 2 hours
Population: All participants that completed the protocol were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Therapy Arm | Detection of Expiratory Flow Limitation | 2.6 cmH2O*s/L |
90% CI: [0, 100]
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.
Time frame: 2 hours
Population: All participants that completed the protocol were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Therapy Arm | Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator | Flow limited | 8 Participants |
| Therapy Arm | Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator | Not Flow Limited | 5 Participants |
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.
Time frame: 2 hours
Population: All participants that completed the protocol were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Therapy Arm | Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique | Flow limited | 534 breaths |
| Therapy Arm | Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique | Not Flow Limited | 567 breaths |
| Therapy Arm | Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique | Indeterminate | 1396 breaths |