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

Testing a device to help patients breathe without a ventilator.

Recruiting
18 years and older
All
Phase N/A

This study is testing a new system called **pdSTIM™**, which helps people who are on mechanical ventilators (machines that help you breathe) to breathe on their own. It works by using **phrenic nerve stimulation**. The phrenic nerve is like a messenger that tells the diaphragm (the muscle that helps you breathe) to move. People who have been on ventilators for at least four days and have tried but failed to stop using the ventilator can join the study. Participants will be put into two groups randomly: one group will receive the usual care plus the pdSTIM system, and the other will get the usual care only. The study will last up to 67 days for each person, and they will be checked up to 60 days after starting. This study checks how fast people can stop using the ventilator and if there are any serious side effects.

  • Participation lasts up to 67 days.
  • Daily stimulation therapy for the treatment group until successful weaning or 30 days.
  • Participants must have been on a ventilator for at least 4 days and failed a weaning attempt.
Study details
    Ventilator Induced Diaphragm Dysfunction

NCT05998018

Stimdia Medical Inc.

13 December 2024

Step 1 Get in touch with the nearest study center
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