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

Primary Purpose

Ventilator-Induced Lung Injury

Status

Completed

Phase

Not Applicable

Locations

Paraguay

Study Type

Interventional

Intervention

LIVE Catheter

About this trial

This is an interventional device feasibility trial for Ventilator-Induced Lung Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Italian Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temporary diaphragmatic pacing

Arm Description

There is no comparator for this study. Single site and all patients are in the treatment allocated group of temporary diaphragmatic pacing with the LIVE Catheter which is inserted via the left jugular vein.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Absence of device related or procedure related adverse events

Assess subject for adverse events status up to 48 hours post procedure

Full Information

NCT ID

NCT03659552

First Posted

May 3, 2018

Last Updated

September 4, 2018

Sponsor

Lungpacer Medical Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03659552

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

May 7, 2018 (Actual)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lungpacer Medical Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventilator-Induced Lung Injury

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single group assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Temporary diaphragmatic pacing

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

LIVE Catheter

Intervention Description

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.

Primary Outcome Measure Information:

Title

Successful insertion of the LIVE Catheter into the left jugular vein and stimulation of phrenic nerves

Description

Time Frame

through study completion, an average of 14 days

Secondary Outcome Measure Information:

Title

Absence of device related or procedure related adverse events

Description

Assess subject for adverse events status up to 48 hours post procedure

Time Frame

through study completion, an average of 14 days

Other Pre-specified Outcome Measures:

Title

Tidal volume assessement

Description

Generation of tidal volume upon delivery of stimulation to the phrenic nerve(s) without spontaneous or ventilator support, as measured by the ventilator

Time Frame

during the procedure only up to 3 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda Clark, RN

Organizational Affiliation

Lungpacer Medical Inc.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Adrian Ebner, MD

Organizational Affiliation

Italian Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Italian Hospital

City

Asunción

State/Province

Casa Zanotti

Country

Paraguay

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Lungpacer may at any time publish the results of and information pertaining to the investigation subject only to compliance with regulatory requirements pertaining to patient protected health information

Citations:

PubMed Identifier

12016605

Citation

Michalek P, Kautznerova D. Combined use of ultrasonography and neurostimulation for therapeutic phrenic nerve block. Reg Anesth Pain Med. 2002 May-Jun;27(3):306-8. No abstract available.

Results Reference

background

PubMed Identifier

5915563

Citation

Escher DJ, Furman S, Solomon N, Schwedel JB. Transvenous pacing of the phrenic nerves. Am Heart J. 1966 Aug;72(2):283-4. doi: 10.1016/0002-8703(66)90456-x. No abstract available.

Results Reference

result

PubMed Identifier

4882945

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. No abstract available.

Results Reference

result

PubMed Identifier

5050104

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. doi: 10.1097/00000542-197207000-00012. No abstract available.

Results Reference

result

PubMed Identifier

3860734

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. doi: 10.1056/NEJM198508153130705.

Results Reference

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PubMed Identifier

2366549

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. 1990 Jul;100(1):108-14.

Results Reference

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PubMed Identifier

8367614

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. doi: 10.1016/0034-5687(93)90065-i.

Results Reference

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PubMed Identifier

8420434

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. doi: 10.1164/ajrccm/147.1.66.

Results Reference

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PubMed Identifier

8897652

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. doi: 10.1016/0034-5687(96)00021-7.

Results Reference

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PubMed Identifier

10065750

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. doi: 10.1038/sj.sc.3100775.

Results Reference

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PubMed Identifier

25271750

Citation

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. doi: 10.1164/rccm.201405-0993LE. No abstract available.

Results Reference

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PubMed Identifier

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Citation

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

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Citation

Linhart M, Nielson A, Andrie RP, Mittmann-Braun EL, Stockigt 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 cryoballoon ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2014 Aug;25(8):859-865. doi: 10.1111/jce.12431. Epub 2014 May 18.

Results Reference

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

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