Ventilator-Induced Lung Injury
Conditions
Brief summary
Study conducted to confirm phrenic nerve stimulation using the a transvenous Phrenic Nerve Stimulator in the left jugular vein.
Detailed description
The Lungpacer Jugular Access Feasibility System is a prototype for the Lungpacer Diaphragm Pacing Therapy System (DPTS) and consists of the LIVE Catheter, a stimulation system with a Multipole Panel Accessory, an airflow sensor and a Heart Rate Data Capture Device. The catheter is intended for inclusion in the commercial product. The stimulation system with a Multipole Panel Accessory and a Heart Rate Data Capture Device is an interim component created to enable initial safety and feasibility testing of the Lungpacer DPTS concept.
Interventions
DEVICELIVE Catheter
Placement of a temporary LIVE Catheter central venous pacing device in the left jugular vein to pace the phrenic nerves and allow recruitment of the diaphragm muscle.
Sponsors
Lungpacer Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Single group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older; * Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent; * Able to undergo general anesthesia (sedation, intubation, and mechanical ventilation); * Acceptable indication for atrial septal defect closure.
Exclusion criteria
* Subject has an ejection fraction of \< 30% * Subject has a co-morbid illness or life expectancy \< 2 years * Subject has experienced an acute myocardial infarction within 72 hours prior to this procedure * Subject is contraindicated for or unwilling to take aspirin or anticoagulants * Subject is in cardiogenic shock * Subject has other cardiovascular disease requiring open heart surgery * Subject is known to have a demonstrated intra cardiac thrombus on echocardiography * Subject has been treated with paralytic medications within 72 hours prior to procedure * Subject has significant thoracic abnormalities such that placement of a left subclavian line would be difficult * Inability to cannulate the left subclavian vein (post-consent exclusion) * Subject has a known or suspected phrenic nerve paralysis * Subject has co-existing temporary or implanted cardiac electrical devices such as a pacemaker or defibrillator * Subject has an active systemic infection or local infection at or around the insertion site * Subject is known or suspected to be pregnant or is lactating * Subject will be unavailable for, or is unwilling to comply with, follow up requirements of the protocol * Subject is currently enrolled in any other study of an investigational drug or device who has received treatment under that protocol with the investigational product during the 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful insertion of the LIVE Catheter into the left jugular vein and stimulation of phrenic nerves | through study completion, an average of 14 days | To determine whether in an anesthetized (sedated, intubated, and mechanically ventilated) patient the LIVE Catheter can be inserted percutaneously in the left jugular vein and, via the electrical stimulator, to transvenously stimulate one or both phrenic nerves causing the diaphragm to contract |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of device related or procedure related adverse events | through study completion, an average of 14 days | Assess subject for adverse events status up to 48 hours post procedure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tidal volume assessement | during the procedure only up to 3 hours | Generation of tidal volume upon delivery of stimulation to the phrenic nerve(s) without spontaneous or ventilator support, as measured by the ventilator |
Countries
Paraguay
Outcome results
None listed