Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access

Ventilator-Induced Lung Injury Clinical Trial

Official title:

Feasibility of Using a Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659552
• Other study ID #: CLN-0012
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: August 30, 2018

Study information

• Verified date: September 2018
• Source: Lungpacer Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study conducted to confirm phrenic nerve stimulation using the a transvenous Phrenic Nerve Stimulator in the left jugular vein.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Injury
• Ventilator-Induced Lung Injury

Intervention

Device:
• LIVE 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.

Locations

Country	Name	City	State
Paraguay	Italian Hospital	Asunción	Casa Zanotti

Sponsors (1)

Lead Sponsor	Collaborator
Lungpacer Medical Inc.

Country where clinical trial is conducted

Paraguay, 

References & Publications (13)

Ahn B, Beaver T, Martin T, Hess P, Brumback BA, Ahmed S, Smith BK, Leeuwenburgh C, Martin AD, Ferreira LF. Phrenic nerve stimulation increases human diaphragm fiber force after cardiothoracic surgery. Am J Respir Crit Care Med. 2014 Oct 1;190(7):837-9. do — View Citation

Allen GM, McKenzie DK, Gandevia SC, Bass S. Reduced voluntary drive to breathe in asthmatic subjects. Respir Physiol. 1993 Jul;93(1):29-40. — View Citation

Aubier M, Murciano D, Lecocguic Y, Viires N, Jacquens Y, Squara P, Pariente R. Effect of hypophosphatemia on diaphragmatic contractility in patients with acute respiratory failure. N Engl J Med. 1985 Aug 15;313(7):420-4. — View Citation

Eisele JH, Noble MI, Katz J, Fung DL, Hickey RF. Bilateral phrenic-nerve block in man: technical problems and respiratory effects. Anesthesiology. 1972 Jul;37(1):64-9. — View Citation

Escher DJ, Ashley W, Ertag W, Parker B, Furman S, Robinson G. Clinical control of respiration by transvenous phrenic pacing. Trans Am Soc Artif Intern Organs. 1968;14:192-7. — View Citation

Escher DJ, Furman S, Solomon N, Schwedel JB. Transvenous pacing of the phrenic nerves. Am Heart J. 1966 Aug;72(2):283-4. — View Citation

Germany R, Joseph S, James K, Kao A. A novel therapeutic approach for the treatment of central sleep apnea: The remede® system. Cardiovasc Revasc Med. 2014 Jun;15(4):235-9. doi: 10.1016/j.carrev.2014.03.007. Epub 2014 Mar 21. — View Citation

Ishii K, Kurosawa H, Koyanagi H, Nakano K, Sakakibara N, Sato I, Noshiro M, Ohsawa M. Effects of bilateral transvenous diaphragm pacing on hemodynamic function in patients after cardiac operations. Experimental and clinical study. J Thorac Cardiovasc Surg — View Citation

Linhart M, Nielson A, Andrié RP, Mittmann-Braun EL, Stöckigt F, Kreuz J, Nickenig G, Schrickel JW, Lickfett LM. Fluoroscopy of spontaneous breathing is more sensitive than phrenic nerve stimulation for detection of right phrenic nerve injury during cryoba — View Citation

McKenzie DK, Allen GM, Gandevia SC. Reduced voluntary drive to the human diaphragm at low lung volumes. Respir Physiol. 1996 Aug;105(1-2):69-76. — View Citation

Michálek P, Kautznerová D. Combined use of ultrasonography and neurostimulation for therapeutic phrenic nerve block. Reg Anesth Pain Med. 2002 May-Jun;27(3):306-8. — View Citation

Mulvey DA, Aquilina RJ, Elliott MW, Moxham J, Green M. Diaphragmatic dysfunction in neuralgic amyotrophy: an electrophysiologic evaluation of 16 patients presenting with dyspnea. Am Rev Respir Dis. 1993 Jan;147(1):66-71. — View Citation

Oo T, Watt JW, Soni BM, Sett PK. Delayed diaphragm recovery in 12 patients after high cervical spinal cord injury. A retrospective review of the diaphragm status of 107 patients ventilated after acute spinal cord injury. Spinal Cord. 1999 Feb;37(2):117-22 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tidal volume assessement	Generation of tidal volume upon delivery of stimulation to the phrenic nerve(s) without spontaneous or ventilator support, as measured by the ventilator	during the procedure only up to 3 hours
Primary	Successful insertion of the LIVE Catheter into the left jugular vein and stimulation of phrenic nerves	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	through study completion, an average of 14 days
Secondary	Absence of device related or procedure related adverse events	Assess subject for adverse events status up to 48 hours post procedure	through study completion, an average of 14 days