Research | Lungpacer Medical

Studying Faster Ventilator
Independence

Lungpacer Medical is currently enrolling patients in a pivotal clinical study, RESCUE 3. The study will help evaluate the safety and efficacy of the device to seek regulatory approval of the AeroPace System.

ClinicalTrials.gov: NCT03783884

Scientific Abstracts/
Presentations

Peer Reviewed
Publications

0 +

Patients
Studied

Outcomes from a Lungpacer Clinical Study Showed

Lungpacer strengthened the diaphragm and improved lung function

246 %

Stronger
Diaphragm(MIP)

128 %

Improved
Lung Function(RSBI)

Positive trending clinical outcomes

7.4 %

Increase in
Ventilator Weaning

7.9 %

Greater
Survival

1.4 Days

Less on a Ventilator

These results from a randomized, controlled trial compared patients treated with Lungpacer therapy to patients treated with the standard of care. Improvement was statistically significant at p<0.05 for MIP and RSBI; p>0.05 for clinical trends. The rate of serious adverse events was the same between both groups. No unanticipated adverse device effects. Device safety events were those commonly reported for central venous catheters.

Published Research

Journal Of Applied
Physiology

Preclinical data: Diaphragm neurostimulation during mechanical ventilation reduces atelectasis and transpulmonary plateau pressure, preserving lung homogeneity and PaO2/FIO2.
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CHEST Journal: Transvenous Diaphragmatic Neurostimulator To Assist Ventilator Weaning In Hospitalized Patients With COVID-19

American Journal of Respiratory and Critical Care Medicine: Transvenous diaphragm neurostimulation mitigates ventilation-induced brain injury

Journal of Applied Physiology: Diaphragm neurostimulation during mechanical ventilation reduces atelectasis and transpulmonary plateau pressure, preserving lung homogeneity and PaO2/FiO2

American Thoracic Society: Temporary transvenous diaphragm neurostimulation in mechanically ventilated patients – Per protocol results from the RESCUE 2 randomized controlled trial.

American Thoracic Society: Transpulmonary Plateau Pressure Is Lower in Pigs Ventilated with A Combination of Volume Control and Temporary Transvenous Diaphragm Neurostimulation

American Thoracic Society: Diaphragm neurostimulation reduces percentages of hippocampal reactive astrocytes and GFAP serum concentrations in pigs mechanically ventilated for 50 hours

American Thoracic Society: Temporary Transvenous Diaphragm Neurostimulation Reduces Driving Pressure in a Preclinical ICU Model

American Thoracic Society: Temporary Transvenous Diaphragm Neurostimulation preserves PaO2/FiO2 when combined with mechanical ventilation.

Critical Care: Systematic review of cognitive impairment and brain insult after mechanical ventilation

Nature Scientific Reports: Brain Injury After 50 Hours of Lung-Protective Mechanical Ventilation in a Preclinical Model

CHEST: Identifying a minority of patients on mechanical ventilation who consume disproportionate resources: A retrospective cohort study

European Respiratory Society Conference: Temporary Transvenous Diaphragm Neurostimulation in difficult-to-wean mechanically ventilated patients – Results of the RESCUE 2 randomized controlled trial

European Respiratory Society Conference: Lung-Protective Mechanical Ventilation for 50 Hours Activates Hippocampal Astrocytes

European Respiratory Society Conference: Lung-Protective Ventilation Decreases Heart Rate Variability in a Non-Inflammatory Porcine Model

CHEST: Pareto principle in the ICU: The case of mechanical ventilation

CHEST Annual Meeting: Lung-Protective Mechanical Ventilation for 50 Hours Injures the Hippocampus

CHEST Annual Meeting: Temporary Transvenous Diaphragm Neurostimulation Therapy With Mechanical Ventilation Mitigates Atrophy In All Diaphragm Myofiber Types

Critical Care Explorations: Temporary Transvenous Diaphragmatic Neurostimulation in Prolonged Mechanically Ventilated Patients: A Feasibility Trial (RESCUE 1)

European Respiratory Society, Resp. Failure & Mech. Vent. Conference: Temporary Transvenous Diaphragm Neurostimulation Distributes Tidal Volume in a More Physiological Pattern Versus Mechanical Ventilation Alone

American Thoracic Society: Economic Outcomes Among Patients Requiring Prolonged Acute vs. Short-term Mechanical Ventilation In The US, 2014-2018: Results From A Multicenter Cohort Study

American Thoracic Society: Early Markers Of The Need For Prolonged Acute Vs. Short-term Mechanical Ventilation In The US, 2014-2018: Results From A Multicenter Cohort Study

American Thoracic Society Conference: Increased Hippocampal Apoptotic Index After 50 Hours of Gold-Standard Mechanical Ventilation in a Pre-Clinical Pig Model

American Thoracic Society Conference: Increased Presence of Neural Pro-Inflammatory Cells in the Hippocampus After 50 Hours of Gold-Standard Mechanical Ventilation in a Pre-Clinical Pig Model

American Thoracic Society Conference: Increased Hippocampal Cytokine-Mediated Neuroinflammation After 50 Hours of Gold-Standard Mechanical Ventilation in a Pre-Clinical Pig Model

American Thoracic Society Conference: Negative Hippocampal Turnover Index After 50 Hours of Gold-Standard Mechanical Ventilation in a Pre-Clinical Pig Model

American Thoracic Society Conference: Transvenous Stimulation of Left and Right Phrenic Nerves Using a Single Catheter Via Jugular Access – A Second Feasibility Study in a Larger Population

American Thoracic Society Conference: Temporary Transvenous Phrenic-Nerve-Stimulated Diaphragm Neurostimulation During Mechanical Ventilation Preserves Homogeneity in Non-Injured Lungs

Society of Critical Care Medicine Congress: Better PaO2/FiO2 with Temporary Transvenous Diaphragm Neurostimulation vs. Mechanical Ventilation Alone

Critical Care Medicine: Characteristics, hospital course, and outcomes of patients requiring prolonged acute vs. short-term mechanical ventilation in the US, 2014-2018

European Respiratory Society Conference: Transvenous Stimulation Thresholds of the Left and Right Phrenic Nerves using a Single Catheter via Jugular Access

American Thoracic Society Conference: Transvenous Phrenic-Nerve-Stimulated Diaphragm Contraction Does Not Increase Lung Inflammation in Non-Injured Porcine Lungs During 50 Hours of Mechanical Ventilation

American Thoracic Society Conference: Transvenous Phrenic-Nerve-Stimulated Diaphragm Contraction During Mechanical Ventilation Decreases Loss of End-Expiratory Lung Volume in Non-Injured Lungs

American Thoracic Society Conference: Transvenous Phrenic Nerve Pacing May Mitigate Ventilation-Induced Diaphragm Atrophy In All Myofiber Types

American Thoracic Society Conference: Transvascular Stimulation of Left and Right Phrenic Nerves Using a Single Catheter Via Jugular Access – A Feasibility Study

American Thoracic Society Conference: Clearance of Large Pulmonary Mucus Plug Allowing Liberation from Mechanical Ventilation Facilitated by Novel Transvenous Phrenic Nerve Pacing Catheter

American Thoracic Society Conference: Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE 1) US Feasibility Clinical Trial

Trials: Temporary Transvenous Diaphragm Pacing vs. Standard of Care for Weaning from Mechanical Ventilation: Study Protocol for a Randomized Trial

American Thoracic Society Conference: Significant Redistribution of Tidal Volume to Posterior Lung Regions During Phrenic Nerve Stimulated Breaths

American Journal of Respiratory and Critical Care Medicine: Mitigation of Ventilator-Induced Diaphragm Atrophy by Transvenous Phrenic Nerve Stimulation

American Journal of Respiratory and Critical Care Medicine: Diaphragm Activation in Ventilated Patients Using a Novel Phrenic Nerve Temporary Pacing Catheter: First-in-Humans Feasibility

American Thoracic Society Conference: Novel Transvenous Phrenic Nerve Pacing System Prevents Diaphragm Atrophy During Mechanical Ventilation: Pre-Clinical Validation in a Porcine Model

Steve Reynolds, MD, to Present Encouraging Preclinical Results with Lungpacer Medical’s Catheter-based Diaphragm Pacing System