Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial
NCT02670460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2016-04-15
Summary
Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.
Conditions
- Ventilator Induced Lung Injury
Interventions
- DEVICE
-
LIVE Catheter
Placement of a temporary LIVE Catheter central venous pacing device in the left subclavian vein to pace the phrenic nerves and allow recruitment of the diaphragm muscle.
Sponsors & Collaborators
-
Lungpacer Medical Inc.
lead INDUSTRY
Principal Investigators
-
Steve Reynolds, MD · Lungpacer Medical
Study Design
- Allocation
- NA
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-31
- Primary Completion
- 2016-04-30
- Completion
- 2016-04-30
Countries
- Paraguay
Study Locations
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