Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-01-24
2026-07-31
Brief Summary
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Detailed Description
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The study is expected to enroll 40 participants at up to 8 centers focusing on North American sites (main focus USA, \> 50% of study enrollment from US site). An interim analysis will be conducted after 30 participants have been enrolled and compelted their study follow-up to reconfirm sample size (adaptive design). Participants will be followed for up to 10 days or until they are successfully extubated (weaned) from mechanical ventilation, expire prior to extubation, or withdraw consent.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Stimulation Group
The intervention group will receive non-invasive stimulation of the phrenic nerve for activation of the diaphragm.
Stimit Activator 1
The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.
Control Group
The control group will not received intervention and will be treated with standard of care.
No interventions assigned to this group
Interventions
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Stimit Activator 1
The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
ALL
No
Sponsors
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Stimit AG
INDUSTRY
Responsible Party
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Principal Investigators
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Laurent Brochard, MD
Role: PRINCIPAL_INVESTIGATOR
St Michael's Hospital Unity Health Toronto
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
St Michael's Hospital Unity Health Toronto
Toronto, , Canada
Countries
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Central Contacts
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Facility Contacts
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Rodolfo Nelson Molina
Role: primary
Matthew Killam
Role: primary
Hailey Russo
Role: primary
Marlene Santos-Taylor
Role: primary
References
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Schreiber AF, Subira C, Sklar M, Santos M, Ko M, Panelli A, Schaller SJ, Theodore D, Rowley DD, Watson D, Bonde P, Baedorf Kassis EN, Talmor DS, Ranieri M, Goligher EC, Slutsky A, Brochard LJ. Multi-center randomized superiority clinical trial in the early phase of mechanically ventilated patients to preserve diaphragm thickness using non-invasive magnetic phrenic nerve stimulation: STIMIT ACTIVATOR 1 pivotal trial. Trials. 2025 Jun 11;26(1):202. doi: 10.1186/s13063-025-08838-2.
Other Identifiers
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D-26606
Identifier Type: -
Identifier Source: org_study_id