Lungpacer Medical

Studying Faster Ventilator Independence

Participating in this study may help you
and others breathe independently

Lungs Icon

Without a strong diaphragm it is impossible to breathe independently1

Artificial breathing support from a ventilator may weaken the diaphragm muscle more than 50% in less than one day2 making it difficult to regain independent breathing.

Lifting Weight Icon

Lungpacer ® is designed as a personal trainer for the diaphragm muscle

Lungpacer's AeroPace™ system is designed to stimulate the nerves that activate the diaphragm with repetitive exercises for 10-20 minutes twice per day to rebuild diaphragm strength and empower natural, independent breathing.3

Lungpacer therapy provides an exciting potential solution
to help mechanically ventilated patients return to
natural breathing more quickly.

Dr. Joseph Shrager - Stanford University School of Medicine

Outcomes from a previous clinical study showed

Lungpacer strengthened

the diaphragm and

improved lung function

246%

Stronger

Diaphragm3

(MIP)

128%

Improved

Lung Function4, 5

(RSBI)

Positive trending clinical outcomes

7.4%

Increase in

Ventilation Weaning3

7.9%

Greater

Survival3

1.4 Days

Less on a Ventilator3

These results from a randomized, controlled trial compared patients treated with Lungpacer therapy to patients treated with the standard of care. The rate of serious adverse events was the same between both groups.

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Watch a brief video showing
how Lungpacer works

Your Participation Matters

Participating in this study will help evaluate the
safety and efficacy of this device to seek FDA approval

Possible benefits of participating

  • Help other patients by taking part in medical research.
  • Potential access to Lungpacer therapy at no cost.
  • Receive more detailed follow-up care which may improve health. 6
  • May receive compensation up to $2,500.

Important considerations

  • Treatment may be more effective, less effective, or the same as compared to standard treatment.
  • Mild or serious adverse effects may occur.
  • More attention to your medical care may be required.

Get Started

Step 1
Qualify

Patients on a ventilator at least 4 days should discuss qualification criteria with your doctor.

Step 2
Consent

Review and complete the Informed Consent Form with your doctor.

Step 3
Participate

Participants will be randomly placed in either a “Control Group” or a “Treatment Group".

Control Group patients receive:

  • Standard care provided to ventilator patients.
  • May receive a typical catheter to deliver fluids and medications.
  • Additional tests to measure progress towards weaning off the ventilator.

Treatment Group patients receive:

  • Everything in Control Group
  • Multi-function AeroPace™ catheter to deliver fluids, medications, and diaphragm stimulations.
  • Twice daily therapy sessions intended to strengthen the diaphragm.
You can leave the study at any time without any impact to your care.

Click Here to Find a Participating Location

Frequently Asked Questions

Lungpacer RESCUE 3 Clinical Study

Lungpacer Therapy

What is Lungpacer therapy?

Lungpacer therapy is an investigational treatment intended to help strengthen the diaphragm, the large muscle beneath the lungs that plays an important part in breathing. While a person is on a mechanical ventilator (or breathing machine), the diaphragm does not get much use, because the ventilator is doing the breathing. As with all muscles, when it is not used, the diaphragm can lose strength which makes it harder for a person to be weaned from (or no longer need) the ventilator. Lungpacer therapy is designed to stimulate the nerves that activate the diaphragm to keep it in ‘shape’ and may help people wean from the ventilator more quickly to regain independent breathing.

How does Lungpacer therapy work?

Lungpacer’s AeroPace™ system is designed as a personal trainer for the diaphragm muscle. AeroPace is designed to stimulate the nerves that activate the diaphragm with repetitive exercises for 10-20 minutes twice per day to rebuild diaphragm strength and empower natural, independent breathing.7

  1. Dres, M., et al. Temporary transvenous diaphragm neurostimulation in difficult-to-wean mechanically ventilated patients – results of the RESCUE 2 randomized controlled trial. Eur Resp J 2020; 56(64): 4352: 246% stronger diaphragm (MIP)/P=0.0010; +7.4% increased ventilator independence/P=0.586; 7.9% greater survival /P=0.216; 1.4 days less dependent on a ventilator/P=0.498. Modified Intent to Treat Subset (mITT).

Why is Lungpacer being studied?

This is the pivotal clinical study, the third in a series of studies necessary to gain FDA approval for Lungpacer technology. This is not an early investigational study.

What does Lungpacer therapy involve?

Most people on mechanical ventilation already have a central venous catheter (CVC) inserted into a vein in the upper left chest or neck area. This sterile tube is commonly used to deliver fluids and medications. The multi-function Lungpacer catheter delivers fluids and medications as well as electrical stimulations for 10-20 minutes, twice per day to stimulate the nerves which activate and exercise the diaphragm. In many cases, the Lungpacer catheter may replace an existing CVC.

Are there other risks with Lungpacer therapy?

Study risks include those that may occur with the use of central venous catheters and the risks of nerve and diaphragm stimulation. These may include the risks of infection, blood vessel damage, or cardiac effects that can occur with use of catheters. Stimulation risks are rare and may include nerve injury or fatigue of the breathing muscle. Your doctor will discuss these and other risks with you.

How many people have received Lungpacer therapy?

Several hundred patients at prominent research institutions in the U.S. and Europe have participated in Lungpacer therapy research over the past five years. RESCUE 3 is the pivotal study - the culmination of all the existing research - and the final step needed to seek FDA approval for Lungpacer.

What results have come from the previous Lungpacer research?

Lungpacer therapy has undergone over five years of clinical research. Outcomes from a previous clinical study showed Lungpacer strengthened the diaphragm 246%1 and improved lung function 128%8, 9 compared to patients who did not receive the therapy. Additionally, patients treated with Lungpacer therapy have shown positive trending clinical outcomes with a 7.4% increase in ventilator weaning, 7.9% increase in survival, and a reduction of 1.4 days of ventilator use compared to patients who did not receive the therapy.7 Participating in this pivotal clinical study will help evaluate the safety and efficacy of this device to seek FDA approval.

  1. Dres, M., et al. Temporary transvenous diaphragm neurostimulation in difficult-to-wean mechanically ventilated patients – results of the RESCUE 2 randomized controlled trial. Eur Resp J 2020; 56(64): 4352: 246% stronger diaphragm (MIP)/P=0.0010; +7.4% increased ventilator independence/P=0.586; 7.9% greater survival /P=0.216; 1.4 days less dependent on a ventilator/P=0.498. Modified Intent to Treat Subset (mITT).
  2. Lungpacer Data on File: 128% improved lung function (RSBI)/P=0.102, not significant. Modified Intent To Treat Subset (mITT).
  3. Dres M, Gama De Abreu M, Similowski T. Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients: Per Protocol Results from the RESCUE-2 Randomized Controlled Trial. Am J of Respir Crit Care Med 2021;203: A4668: 167% improved lung function (RSBI)/P=0.0487.

What is “FDA Breakthrough Designation”?

The U.S. Food and Drug Administration (FDA) granted this important designation to Lungpacer in recognition of its potential to provide more effective treatment than the standard of care available today for patients who have difficulty getting off of mechanical ventilation. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices like Lungpacer by prioritizing their development, assessment, and regulatory review consistent with the Agency's mission to protect and promote public health. More information at https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

Who is Lungpacer Medical?

The Lungpacer Medical team is comprised of highly experienced clinical research and engineering teams dedicated to developing technologies to empower independent breathing and free patients from the trauma of mechanical ventilation. Lungpacer Medical is headquartered in Vancouver, Canada with U.S. operations in Exton, Pennsylvania, and team members throughout Europe. More information at www.lungpacer.com

RESCUE 3 Study Participation

What is the RESCUE 3 clinical study?

“RESCUE 3” is the name of the study evaluating Lungpacer therapy as a way to help people gain independence from mechanical ventilation as quickly as possible. The RESCUE 3 clinical study results are intended to help gain approval of Lungpacer therapy from regulatory authorities, such as the FDA in the U.S., to allow its use in hospitals and clinics. Regulatory authorities in the U.S. (FDA) and Europe (Notified Bodies) approve all new medical devices before they can become commercially available in these countries.

Why should someone participate in the RESCUE 3 study?

Without clinical studies, and the people who participate in them, new technologies that truly make a difference in people’s care may not be made available. The RESCUE 3 study is a pivotal study and final step to allow Lungpacer therapy to potentially gain regulatory approval so that it is available to more patients who struggle to breath independently without a ventilator.

How long will the study last?

The Lungpacer treatment concludes as soon as the patient weans off the ventilator, but patients are followed for up to 32 days. Patients can leave the study at any time without any impact on their care.

What should study participants expect?

The RESCUE 3 study is a randomized study. All qualifying patients will receive additional care and attention from their care teams and the study clinical research team to monitor progress which may improve health outcomes,10 but half of the patients enrolled will additionally receive Lungpacer therapy, which may help them wean off a ventilator more quickly than patients who are not using Lungpacer therapy. Patients are randomly assigned to a group (like the flip of a coin). Those in the study, whether receiving quality care alone or along with Lungpacer therapy, can expect additional visits from their healthcare staff to closely monitor progress.

  1. Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler WB, Armstrong PW. Better Outcomes for Patients Treated at Hospitals That Participate in Clinical Trials. Arch Intern Med. 2008;168(6):657–662.

If participating in the study, will everyone automatically receive the Lungpacer therapy

The RESCUE 3 study will consist of two groups. One group, commonly called the Control group, will receive additional care and attention from their care teams and the study clinical research team to monitor progress which may improve health outcomes.10 The second group, the Treatment group, will receive that same quality care as the Control group and will also receive Lungpacer therapy. Whether or not a participant receives therapy is randomly assigned (like the flip of a coin) and your study team does not have any influence on the decision. Randomly assigning participants into the two groups is a trusted scientific methodology and will help determine whether Lungpacer therapy shows benefits over current care alone.

  1. Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler WB, Armstrong PW. Better Outcomes for Patients Treated at Hospitals That Participate in Clinical Trials. Arch Intern Med. 2008;168(6):657–662.

If a study participant doesn’t receive Lungpacer therapy, what should they expect for treatment?

If a study participant is randomly chosen to not receive Lungpacer therapy (called the Control group), they will receive additional care and attention from their care teams and the study clinical research team to monitor progress which may improve health outcomes.10 Their medical status will be monitored as closely as those who were randomly chosen to receive Lungpacer therapy.

  1. Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler WB, Armstrong PW. Better Outcomes for Patients Treated at Hospitals That Participate in Clinical Trials. Arch Intern Med. 2008;168(6):657–662.

Is participation in the study recommended if a person is progressing towards being able to breath on their own without the mechanical ventilator?

Lungpacer is designed to strengthen the diaphragm to gain ventilator independence as quickly as possible. Your physician will discuss your eligibility to participate in the study. The study requires that participants are well enough that they can try to stop using the mechanical ventilator and start to breathe on their own. Participants must have been on a mechanical ventilator for at least four days and have made at least two unsuccessful attempts to be weaned from mechanical ventilation.

What if a participant no longer wants to participate in the RESCUE 3 study?

Participation in the RESCUE 3 study is completely voluntary. Patients can leave the study at any time without any impact on their care by speaking with their treating physician.

Financial

Will I be compensated for participation in the study?

If permitted by the study site and the Institutional Review Board (IRB), study participants may be compensated up to $2,500. Family members may be reimbursed for expenses such as travel that are incurred during the consenting process.

Does being part of the RESCUE 3 study cost anything?

Participation in the study will not cost anything to the study participant. The company sponsoring the study, Lungpacer Medical, will cover the costs of the therapy as well as any other costs directly associated with the clinical study, when permitted.

Do I need insurance coverage to participate?

Additional insurance is not needed to cover the costs of the therapy. Lungpacer Medical covers all costs associated with the care provided for the clinical study. Costs related to general medical treatment and any additional needed medical care not related to the clinical study will not be impacted by participation in the clinical study. Please consult your health insurance provider to discuss specific questions about your coverage.

Lungpacer's AeroPace System

AeroPace stimulates the nerves that activate the diaphragm muscle, the source of natural breathing. For patients unable to breathe on their own, the AeroPace therapy provides repetitive exercises to rebuild diaphragm muscle strength critical to healthy breathing. Lungpacer is an FDA Breakthrough Device.

AeroPace Catheter

The multi-function AeroPace catheter can be used to provide fluids and medications and is similar in size and shape to a typical catheter. The AeroPace catheter additionally delivers small energy stimulations to targeted nerves in the upper body to activate and exercise the diaphragm.

  1. Jubran A, Tobin MJ. Pathophysiologic basis of acute respiratory distress in patients who fail a trial of weaning from mechanical ventilation. Am J Respir Crit Care Med. 1997;155:906–15.
  2. Levine S, et al. Rapid Disuse Atrophy of Diaphragm Fibers in Mechanically Ventilated Humans. N Engl J Med. 2008 27 Mar; 358(13): 1327-35.
  3. Dres, M., et al. Temporary transvenous diaphragm neurostimulation in difficult-to-wean mechanically ventilated patients – results of the RESCUE 2 randomized controlled trial. Eur Resp J 2020; 56(64): 4352: 246% stronger diaphragm (MIP)/P=0.0010; +7.4% increased ventilator independence/P=0.586; 7.9% greater survival /P=0.216; 1.4 days less dependent on a ventilator/P=0.498. Modified Intent to Treat Subset (mITT).
  4. Lungpacer Data on File: 128% improved lung function (RSBI)/P=0.102, not significant. Modified Intent To Treat Subset (mITT).
  1. Dres M, Gama De Abreu M, Similowski T. Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients: Per Protocol Results from the RESCUE-2 Randomized Controlled Trial. Am J of Respir Crit Care Med 2021;203: A4668: 167% improved lung function (RSBI)/P=0.0487. Per Protocol (PP) group received at least 50% of Lungpacer therapy sessions.
  2. Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler WB, Armstrong PW. Better Outcomes for Patients Treated at Hospitals That Participate in Clinical Trials. Arch Intern Med. 2008;168(6):657–662.