Non-invasive treatment for diaphragm issues in ventilated patients

STIMIT Activator 1 Pivotal Study

This study is testing a new non-invasive device to see if it can help patients who are on a ventilator for breathing issues get better and breathe on their own again.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Stimit AG (Industry-sponsored)
• Locations: 4 sites (New Haven, Connecticut and 3 other locations)
• Trial ID: NCT05883163 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the safety and efficacy of the STIMIT Activator 1 device in patients who have been on invasive mechanical ventilation for up to 48 hours and are expected to require additional ventilation. The study is a prospective, multi-center, randomized, controlled trial using an adaptive design, aiming to include 40 subjects across up to 6 centers primarily in the USA. An interim analysis will be conducted after 30 patients to confirm the sample size, with a follow-up period of 10 days or until successful extubation. The study is anticipated to commence upon regulatory approvals.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older who have been on invasive mechanical ventilation for 48 hours or less and are predicted to need it for at least another 48 hours.

Not a fit: Patients who are planned to receive continuous neuromuscular blocking agents beyond the enrollment period or have severe chronic pulmonary diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve diaphragm function and reduce the duration of mechanical ventilation for patients.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in non-invasive stimulation techniques for respiratory issues.

Eligibility criteria

Inclusion Criteria:

1. Are 21 years or older, and,
2. Have recently been placed on invasive MV (enroll and randomized as soon as possible after intubation), and have received no more than 7 days of MV
3. Are predicted to remain on mechanical ventilation for an additional 48 hours or longer post randomization

Exclusion Criteria:

1. Patients that are actively treated with continuous infusion of neuromuscular blocking agents beyond the enrollment period.
2. Medical condition known to affect the phrenic nerve or respiratory muscles (examples of possible medical conditions that could affect the phrenic nerve provided in Annex 1 below).
3. Any patients with ICP probe.
4. Patients with metallic device implants or body penetrating metallic devices in the upper body area within 30cm (12inches) from the coils; known anatomy or devices in the neck area (e.g., ECMO cannulas in the neck area, collars or cranial appliances) that would interfere with headset placement or stimulation.
5. Any non-removable electrical / electronic device (device internal or external) that may be prone to interaction with, or interference from the STIMIT Activator, such as pacemakers, implantable defibrillators, implanted medication pumps, bio-stimulators, deep brain stimulators, implanted nerve stimulator, deep brain stimulators or cochlear device implants.
6. BMI \>40.
7. Cardiogenic or septic shock with ongoing severe hemodynamic instability that cannot be stabilized within the enrollment period.
8. Physician thinks that the patient will not tolerate initial installation of the STIMIT respiratory sensor.
9. Anticipating withdrawal of life support and/or shift to palliation as the goal of care.
10. Known to be pregnant.
11. Participating in another clinical trial studying an experimental Intervention that could affect the study primary outcome.
12. Patients whose ultrasonographic assessment of right-sided diaphragmatic thickness would be too difficult (e.g. local subcutaneous emphysema surrounding the zone of apposition, large dressings in the zone of apposition that cannot be removed).
13. Patients with neck condition that would not allow placing the coils on the neck (e.g. open wounds that cannot be covered, skin at risk for burns).
14. Patients with significant spontaneous efforts (P0.1 \< - 2) that would not be at risk for diaphragmatic atrophy/ dysfunction.

Where this trial is running

New Haven, Connecticut and 3 other locations

• Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
• University of Virginia Medical Center — Charlottesville, Virginia, United States (Recruiting)
• St Michael's Hospital Unity Health Toronto — Toronto, Canada (Recruiting)

Study contacts

• Principal investigator: Laurent Brochard, MD — St Michael's Hospital Unity Health Toronto
• Study coordinator: Tsiry Rabemahefa

Conditions Diaphragm Issues; Non-Invasive Phrenic Nerve Stimulation