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Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients

Study on pdSTIM™ system for patients on ventilators.

Recruiting
18 years and older
All
Phase N/A

This study is looking at a new way to help people who have trouble stopping the use of a machine that helps them breathe, called a mechanical ventilator. The study involves a device called the pdSTIM System, which uses phrenic nerve stimulation to help the breathing muscle, the diaphragm, work better. The phrenic nerve is a nerve that tells the diaphragm when to move. This study will compare how well people do with the pdSTIM System and without it (standard care).

To join, you need to be at least 18 years old and have been on a ventilator for at least 4 days. If you have tried to stop using the ventilator and couldn't, you might be eligible. You cannot join if you’ve been using a ventilator for more than 45 days or have certain health conditions like severe lung disease or recent neck cancer.

  • The study lasts up to 67 days, including follow-up.
  • You may receive daily stimulation therapy if assigned to the Treatment group.
  • Participants are randomly selected to receive the pdSTIM or standard care.
Study details
    Ventilator Induced Diaphragm Dysfunction

NCT05998018

Stimdia Medical Inc.

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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