N/A
Completed N=22
Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation
Source: ClinicalTrials.gov NCT01151618 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Detection of Expiratory Flow Limitation — 2.6 cmH2O*s/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection of Expiratory Flow Limitation |
2.6 | — |
| PRIMARY Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator |
8; 5 | — |
| PRIMARY Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique |
534; 567; 1396 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01151618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.