AeroPace Diaphragm Pacing Therapy for Ventilator-Dependent Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This was a prospective, multicenter, single-arm study collecting real-world data after the AeroPace diaphragm pacing therapy was approved. It enrolled adults on mechanical ventilation for at least four days who had failed a spontaneous breathing trial and continued to require support. The primary focus is 30-day safety and continued effectiveness of the AeroPace system when used in routine clinical practice. Data from participating centers will help characterize outcomes related to diaphragmatic function and weaning in this specific population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Are 18 years or older, and,
2. Will have been mechanically ventilated for ≥96 hours (4 days) by the time of Catheter insertion, and,
3. Have not weaned from MV, and,
4. Have failed an institutional SBT within 48 hours of enrollment.

Exclusion Criteria:

1. Invasive mechanical ventilation \>90 days.
2. Currently on extracorporeal membrane oxygenation (ECMO).
3. Weaning failure due to hypervolemia.
4. Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.
5. Clinically overt congestive heart failure that is preventing weaning.
6. Currently being treated with neuromuscular blockade that could affect phrenic nerve / diaphragm contraction.
7. Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles.
8. Pre-existing severe chronic pulmonary fibrosis.
9. Known pleural effusions occupying greater than one third of the pleural space on either side.
10. BMI \>70 kg/m2.
11. Known or suspected phrenic nerve paralysis.
12. Any electrical device (implanted or external) that may be prone to interaction with, or interference from the AeroPace System, including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators.
13. Current hemodynamic instability
14. Uncontrolled sepsis or septic shock.
15. Current or untreated bacteremia.
16. Expecting withdrawal of life support and/or shift to palliation as the goal of care.
17. Known or suspected to be pregnant or lactating.
18. Currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.

Where it's running

• Sutter Health Research Institute
  San Francisco, California, United States Recruiting

Study contacts

• Study coordinator: Megan Cotts
• Email: mcotts@lungpacer.com
• Phone: (612) 986-7172

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Shenfu Injection to help wean and reduce ventilator dependence in adults on mechanical ventilation

  This trial tests whether Shenfu Injection, added to standard care, helps critically ill adults on invasive ventilation breathe without the machine sooner and reduces diaphragm dysfunction.

  Recruiting The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Yiwu, Zhejiang · NCT07880977

• heepSync: synchronized electrical stimulation of breathing muscles for adults on mechanical ventilation

  This trial tests whether the heecap heepSync algorithm can safely sync electrical stimulation to breathing muscles in adults on mechanical ventilation.

  Recruiting at 3 sites Tesai Care SL · Barcelona, Barcelona and 2 other locations · NCT07363902

• Impact of Early Mobilization on Diaphragm Thickness in Critically Ill Children

  This study is testing if getting critically ill children moving early while they are on a ventilator can help keep their diaphragm stronger compared to just regular care.

  Recruiting Children's Hospital of Fudan University · Shanghai · NCT04534296

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.