Trial Outcomes & Findings for PEPNS System Feasibility Study (NCT NCT03559933)

Results Overview

Capture of the Left and/or Right Phrenic Nerve \> 80% with an output parameter of \< 10.5 volts. Capture was defined as diaphragmatic movement as a direct consequence of electrical phrenic nerve stimulation. Capture for this analysis was defined as synchrony of the stimulated breath with the output parameter \<10.5 volts and Work of Breath between 0.2 and 2.0 Joules/L. Synchrony was achieved if the lag time between start of inspiration and start of stimulation was less than 88 ms. The proportion of successful capture was analyzed using a generalized linear mixed model accounting for subject and stimulation within subject as random effects, and the outcome of capture was yes/no based on whether the stimulation captures the diaphragm with multiple observations per subject.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Up to 48 hours

Results posted on

2021-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PEPNS System Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy n=12 Participants Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.
Age, Continuous	61.9 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants
BMI	29.1 kg/m^2 STANDARD_DEVIATION 6.6 • n=5 Participants
Neck Circumference at the Cricoid Cartilage	44.6 centimeter STANDARD_DEVIATION 5.3 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 48 hours

Population: 10 patients with bilateral lead placement (excluding the initial two patients with left-sided lead placement only)

Capture of the Left and/or Right Phrenic Nerve \> 80% with an output parameter of \< 10.5 volts. Capture was defined as diaphragmatic movement as a direct consequence of electrical phrenic nerve stimulation. Capture for this analysis was defined as synchrony of the stimulated breath with the output parameter \<10.5 volts and Work of Breath between 0.2 and 2.0 Joules/L. Synchrony was achieved if the lag time between start of inspiration and start of stimulation was less than 88 ms. The proportion of successful capture was analyzed using a generalized linear mixed model accounting for subject and stimulation within subject as random effects, and the outcome of capture was yes/no based on whether the stimulation captures the diaphragm with multiple observations per subject.

Outcome measures

Outcome measures
Measure	Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy n=36059 Stimulated Breaths Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.
Percent Capture of Left and/or Right Phrenic Nerve	96.56 percentage of phernic nerve capture

PRIMARY outcome

Timeframe: Up to 48 hours

Work of Breathing (WOB) kept between 0.2 and 2.0 joules/L for 80% of stimulated breaths. Outcome is measured as a percentage of stimulated breaths that had a WOB between 0.2 joules/L and 2 joules/L and the performance goal was 80%.

Outcome measures

Outcome measures
Measure	Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy n=36059 Stimulated Breaths Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.
Percent of Breaths Within Work of Breathing Range	96.77 percentage of stimulated breaths Interval 96.58 to 96.95

SECONDARY outcome

Timeframe: Up to 48 hours

The percentage of patients who receive safe and successful placement of the multipolar lead in the left and right phrenic nerve utilizing ultrasound guidance will be determined.

Outcome measures

Outcome measures
Measure	Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy n=10 Participants Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.
Safe and Successful Lead Placement	100 percentage of patients

SECONDARY outcome

Timeframe: Up to 48 hours

Phrenic nerve stimulation in synchrony with Mechanical Ventilation breaths will be measured to verify that is occurs with inspiration.

Outcome measures

Outcome measures
Measure	Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy n=10 Participants Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.
Phrenic Nerve Stimulation Effectiveness	100 percentage of patients

SECONDARY outcome

Timeframe: Up to 48 hours

The percentage of patients who experience one or more serious device/procedure-related adverse events during the study will be reported.

Outcome measures

Outcome measures
Measure	Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy n=10 Participants Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.
Serious Device/Procedure Related Adverse Events	0 percentage of patients

Adverse Events

Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy

Serious events: 4 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy n=12 participants at risk Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.
Nervous system disorders Patient Death	33.3% 4/12 • Number of events 4 • Adverse event data was collected during the therapy period (48 hours) and additional 30-37 days until follow-up.

Other adverse events

Adverse event data not reported

Additional Information

Tim Miller

Stimdia Medical, Inc.

Phone: 612.940.3454

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place