SESSION TITLE: Pulmonary Rehabilitation Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: We evaluated the effects of a novel ventilator system on exercise endurance in subjects with chronic respiratory disease. The Tidal Assist Ventilation (TAV) System comprises a small, lightweight (3.8 ounce) device and nasal pillows interface that operates using oxygen from a concentrator, tank, or wall source. The TAV provides a synchronized bolus of oxygen with entrained air and positive inspiratory pressure. In vitro, the TAV delivers inspiratory flow rates up to 100 lpm and proximal airway pressures up to 20 cmH20.
METHODS: Following IRB approval, subjects with moderate-to-very severe oxygen-dependent chronic lung disease were enrolled. At Study Visit 1, baseline physiologic measures were obtained and subjects received training on riding a cycle ergometer and using the TAV System. Peak work rate (PWR) exercise levels and supplemental oxygen flow rates for oxygen cannula and TAV were established. During Study Visit 2, each subject exercised at a constant work rate (CWR) of 80% of PWR to maximum endurance while using both the TAV system and supplemental oxygen via standard cannula, in random order.
RESULTS: Eighteen subjects (9F/9M) with COPD (GOLD 2=1, GOLD 3=7, GOLD 4=7) or ILD (n=3) completed the study. Mean ± SD age and CWR were 69 ± 8.1 years and 28.7 ± 10.8 watts, respectively. Mean CWR exercise time was significantly longer using the TAV System vs. standard oxygen (13.7 ± 10.5 vs. 6.3 ± 2.9 minutes, p=0.0021, 95% CI=3.1 to 11.6). TAV System use was also associated with significant isotime improvements in: - SpO2: 96.8% vs. 90.8%, p=0.0001 - Borg10 Dyspnea Score: 3.8 vs. 6.1, p=0.0002 - Leg Fatigue10 Score: 3.7 vs. 5.6, p=0.0012 The TAV System was well tolerated and no serious adverse events were observed during the study.
CONCLUSIONS: The TAV System significantly increased mean exercise time and improved isotime SpO2, dyspnea and leg fatigue scores compared to standard oxygen therapy.
CLINICAL IMPLICATIONS: The TAV System offers a highly portable means to improve exercise tolerance, oxygenation, and dyspnea in patients with chronic respiratory disease.
DISCLOSURE: Lana Hilling: Grant monies (from industry related sources): Research funding from New Aera, Inc. for clinical trial performance Cindy Cayou: Grant monies (from industry related sources): Funding from New Aera, Inc. related to clinical trial performance Richard Kops: Consultant fee, speaker bureau, advisory committee, etc.: Consulting fee related to clinical development from New Aera, Inc. Richard Morishige: Consultant fee, speaker bureau, advisory committee, etc.: Consulting fees related to clinical trial planning and execution from New Aera, Inc. Nicholas Hill: Consultant fee, speaker bureau, advisory committee, etc.: Consulting fee related to clinical development from New Aera, Inc.
This abstract discusses clinical trial results involving the use of a portable ventilation system called the Tidal Assist Ventilation (TAV) System during constant work rate exercise. The TAV system is not currently FDA cleared, but is in the process of submission to FDA for 510(k) clearance.