STIMIT Activator 1 Pivotal Study
Study Details
Study Description
Brief Summary
The study is a prospective, multi-center, randomized, controlled study using adaptive design to assess the evidence of safety and performance of the STIMIT Activator 1 System in the treatment of patients who have been mechanically ventilated for up to 48 hours and are predicted to require additional minimum 48 hours of mechanical ventilation or longer (adding up to MV time approximately 96 hours or longer).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The objective of this clinical investigation is to evaluate the safety and efficacy of the STIMIT Activator 1 device in subjects on mechanical ventilation who are on invasive mechanical ventilation (MV) and thus are at risk of diaphragmatic dysfunction/atrophy.
The study is a prospective, multi-center, randomized, controlled study using adaptive design to assess the evidence of safety and performance of the STIMIT Activator 1 System in the treatment of patients who have been mechanically ventilated for up to 48 hours and are predicted to require additional minimum 48 hours of mechanical ventilation or longer (adding up to MV time approximately 96 hours or longer).
This pivotal study is expected to include 40 subjects enrolled and device interventions in up to 6 centers focusing on North American sites (main focus USA, > 50% of study enrollment from US site). An interim analysis will be conducted after 30 patients have been treated to reconfirm sample size (adaptive design). This clinical study is anticipated to commence in the US upon approval by FDA and local IRB/EC site approval, and Canada upon approval of competent authorities and Ethics Committees. Enrollment and 10- day follow-up duration for primary endpoint of the study is expected to last 6 months. Subjects will be followed for 10 days or until they are successfully extubated (weaned) from mechanical ventilation, expire, or withdraw consent.,
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Stimulation Group The treatment group will receive non-invasive stimulation of the phrenic nerve for activation of the diaphragm. |
Device: Stimit Activator 1
The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.
|
| No Intervention: Control Group The control group will not received intervention and will be treated with standard of care. |
Outcome Measures
Primary Outcome Measures
- Preservation of Diaphragm Thickness [Up to 10 days or extubation, whichever occurs first.]
The intra-individual change in diaphragm thickness will be measured daily via ultrasound.
- the rate of device or treatment related serious adverse events [Up to 10 days or extubation, whichever occurs first.]
Events will be collected for treatment group during the course of treatment.
Secondary Outcome Measures
- Preservation of Diaphragm Thickness [Up to Day 4.]
The intra-individual change in diaphragm thickness will be measured daily via ultrasound.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed consent in writing from patient or the legally authorized representative
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Are 21 years or older, and,
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Have been on invasive mechanical ventilation ≤ 48hours and are predicted to remain on MV for an additional 48 hours or longer*
- Prediction at time of enrollment
Exclusion Criteria:
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Patients that are planned to be treated with continuous infusion of neuromuscular blocking agents beyond the 48h enrollment period.
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Medical condition known to affect the phrenic nerve or respiratory muscles (non-exclusive list of medical conditions that could affect the phrenic nerve provided in Annex 1 below)
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Patients with elevated intracranial pressure (ICP) (ICP ≥ 20mmHg (Aiolfi et al. 2017) (Kristiansson et al. 2013)) that require therapeutic intervention (i.e. therapeutic PaCO2 levels)to help contain intracranial pressure
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Pre-existing severe chronic pulmonary disease (COPD GOLD stage IV, severe pulmonary fibrosis)
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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
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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
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BMI >40
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Cardiogenic or septic shock with ongoing severe hemodynamic instability as defined according to American College of Chest Physicians (Bone et al. 1992) (Singer et al. 2016)) that cannot be stabilized within the 48 hours enrollment period
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Patients who are likely to suffer from atelectasis due to temporary removal of PEEP during installation of the STIMIT respiratory sensor.
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Anticipating withdrawal of life support and/or shift to palliation as the goal of care (refer to Annex 2)
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Known to be pregnant
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Participating in another clinical trial studying an experimental Intervention that could affect the study primary outcome.
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Patients with presence of a right-side chest drain, right-side pleural effusion, or co-existing pulmonary consolidation in the right lower lobe, which may limit ultrasonographic assessment of right-sided diaphragmatic thickness.
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Patients with any neck incision, bruising, or other skin condition that places the subject at risk for burns.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Stimit AG
Investigators
- Principal Investigator: Laurent Brochard, MD, St Michael's Hospital Unity Health Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D26606