STIMIT Activator 1 IDE Study
ConditionDiaphragm Issues
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorStimit AG
About this trial
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 7 days and are predicted to require additional minimum 48 hours of mechanical ventilation or longer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are 21 years or older, and,
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
Are predicted to remain on mechanical ventilation for an additional 48 hours or longer post randomization
Disqualifiers
Patients that are actively treated with continuous infusion of neuromuscular blocking agents beyond the enrollment period.
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).
Any patients with ICP probe.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Stimit Activator 1
DeviceThe Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Stimulation GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Efffectiveness: Preservation of Diaphragm Thickness
The intra-individual change in diaphragm thickness will be measured daily via ultrasound and compared between intervention and control groups.
Time frame
Up to Day 102
Safety: Rate of device or procedure related serious adverse events (SAEs)
Events will be collected for intervention group during the course of treatment.
Time frame
Up to Day 10Secondary outcomes
1
Preservation of Diaphragm Thickness
The intra-individual change in diaphragm thickness will be measured daily via ultrasound and compared between intervention and control groups.
Time frame
Up to Day 32
Time to Rapid Shallow Breathing Index (RSBI) < 105
Time from intubation to RSBI\<105 breaths/min/L in days will be compared between intervention and control groups.
Time frame
Up to Day 103
Maximum Inspiratory Pressure (MIP) at extubation
MIP at extubation will be compared between intervention and control groups.
Time frame
Up to Day 10 Source ClinicalTrials.gov