RecruitingNAINTERVENTIONAL

STimulation to Activate RespIration

This study, called "STimulation to Activate RespIration," is exploring a new treatment for patients in intensive care who are struggling to breathe, often due to conditions like severe lung injury (ARDS). These patients are usually on a breathing machine (ventilator). The new method involves a mild electrical stimulation to a nerve called the phrenic nerve, which helps control your diaphragm – your main breathing muscle. Researchers want to see if this type of stimulation, alongside standard breathing support, can help patients breathe better and potentially recover faster. It's a key step in finding better ways to support very sick patients and help them get off breathing machines.

At a glance

Status

Recruiting

Phase

Sponsor

Lungpacer Medical Inc.

Enrolment target

Start

28 May 2025

Estimated completion

01 Dec 2026

ARDS (Moderate or Severe)AHRF Mechanically Ventilated ICU Patients

What is this study about?

This study is investigating a new approach to help patients who are very ill and need a breathing machine, also known as a mechanical ventilator, in the intensive care unit (ICU). These patients often have severe lung problems, such as Acute Respiratory Distress Syndrome (ARDS) or Acute Hypoxemic Respiratory Failure (AHRF), which make it very hard for them to breathe on their own. When you're on a breathing machine, your own breathing muscles, especially your diaphragm, can become weak over time. This new treatment aims to keep these muscles active.

The treatment involves something called phrenic nerve stimulation. The phrenic nerve is like an electrical wire that sends signals from your brain to your diaphragm, telling it to contract so you can breathe in. In this study, a special device called the AeroNova System provides gentle electrical pulses to this nerve. The idea is that by stimulating the nerve, your diaphragm muscle can stay stronger and more active while you're on the ventilator. This might help you to breathe more effectively and potentially come off the breathing machine sooner.

The study wants to compare this new method with the standard care, which involves specific techniques to protect the lungs while on a ventilator. Some patients will receive the new nerve stimulation treatment along with standard care, while others will just receive standard care. This will help doctors understand if adding phrenic nerve stimulation makes a positive difference for patients struggling to breathe in the ICU. It’s an important step in improving care for those with severe breathing difficulties.

Key takeaways

The study explores a new method to help critically ill patients on breathing machines.
It uses mild electrical pulses to strengthen the main breathing muscle, the diaphragm.
The aim is to see if this helps patients recover and breathe on their own faster.
Participants will either receive standard care or standard care plus the new stimulation.
The study is important for finding better ways to support patients with severe lung problems.

Who may be eligible?

To be considered for this study, you would generally need to be at least 18 years old and currently in intensive care, needing a breathing machine for a breathing problem that started recently. Your breathing difficulty needs to be due to low oxygen levels in your blood, and you should have been on the breathing machine for less than four days. Also, your medical team should expect that you'll need the breathing machine for at least two more days after joining the study.

There are also some reasons why you might not be able to join. For example, if your breathing problems are mainly caused by conditions like severe asthma, chronic lung diseases (like severe COPD or lung scarring), or if you already have certain nerve or muscle problems that affect your breathing. You also can't join if you're on a heart-lung bypass machine (ECMO) or if you're expected to receive only comfort care within 72 hours. The study also cannot include people with a very high body mass index (BMI) over 70, or if there are medical reasons you can't have a special type of drip placed in a particular vein.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently in intensive care on a breathing machine due to recent breathing problems?
Have you been on the breathing machine for less than 4 days?
Is your medical team expecting you to need the breathing machine for at least 2 more days?
Do you have a clear understanding, or does your legal representative, about being part of a study?

Answer every question to see your result.

What does participation involve?

If you, or your representative, agree for you to take part in this study, you would be randomly assigned to one of two groups: either receiving the new nerve stimulation treatment along with standard breathing support, or receiving standard breathing support alone. The nerve stimulation involves a thin wire being placed near the phrenic nerve, which delivers the gentle electrical pulses. This is a common procedure, similar to placing a central line for medication. There will be regular checks by the medical team to see how you are responding to treatment.

Since you are already in the ICU and on a breathing machine, many of the assessments and monitoring will be part of your routine care. The study would involve additional monitoring specifically related to the nerve stimulation. The total duration of your participation in the study largely depends on how long you need the breathing machine and your recovery process within the ICU. There are no additional visits outside of your hospital stay.

Potential risks and benefits

Participating in this study might offer a potential benefit if the nerve stimulation helps to keep your breathing muscles stronger, possibly leading to a quicker recovery and getting off the breathing machine sooner. However, as with any medical procedure, there are potential risks, such as those associated with placing the stimulation wire. While these are usually minor, like a small bruise or infection risk at the site, your medical team will constantly monitor you for any complications. It's important to remember that you, or your legally authorised representative, have the right to withdraw from the study at any time without affecting your medical care.

Locations (6)

University of California San Diego
Verified postcode
La Jolla, United States· Recruiting
Louisiana State University Health Sciences
Verified postcode
Shreveport, United States· Recruiting
Cleveland Clinic
Verified postcode
Cleveland, United States· Recruiting
Temple University
Verified postcode
Philadelphia, United States· Recruiting
Prisma Health
Verified postcode
Columbia, United States· Recruiting
University Health Network (UHN)
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a severe lung condition where fluid builds up in the air sacs of your lungs, making it very difficult to breathe and for oxygen to get into your blood.

What is a ventilator?

A ventilator is a machine that helps you breathe when your lungs are too weak or sick to do it on their own. It pushes air into your lungs and helps you exhale.

What is the phrenic nerve?

The phrenic nerve is a nerve that controls your diaphragm, which is the main muscle that helps you breathe. It sends signals from your brain to make your diaphragm contract.

Will I feel the nerve stimulation?

While you're likely to be sedated (medicated to make you drowsy and comfortable) in the ICU, the stimulation is designed to be gentle. Your medical team will ensure you are comfortable throughout the procedure.

Is this a new treatment?

This specific use of phrenic nerve stimulation to help patients on ventilators is a new approach being investigated in this study. It builds on existing medical knowledge but is not yet standard practice.

How to find out more

Megan O'Toole

motoole@lungpacer.com (484) 350-4530 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.