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

NCT03659552 | Completed

• 1 other identifier: CLN-0012
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventilator-Induced Lung Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Absence of device related or procedure related adverse events

  through study completion, an average of 14 days

Other Outcomes (1)

• Tidal volume assessement

  during the procedure only up to 3 hours

Study Arms (1)

Temporary diaphragmatic pacing

EXPERIMENTAL

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.

Device: LIVE Catheter

Interventions

LIVE Catheter DEVICE

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.

Temporary diaphragmatic pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Lungpacer Medical Inc.: lead

Study Sites (1)

Italian Hospital

Asunción, Casa Zanotti, Paraguay

Location

Related Publications (13)

• 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.

  PMID: 12016605 BACKGROUND

• 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.

  PMID: 5915563 RESULT

• 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.

  PMID: 4882945 RESULT

• 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.

  PMID: 5050104 RESULT

• 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.

  PMID: 3860734 RESULT

• 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.

  PMID: 2366549 RESULT

• 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.

  PMID: 8367614 RESULT

• 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.

  PMID: 8420434 RESULT

• 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.

  PMID: 8897652 RESULT

• 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.

  PMID: 10065750 RESULT

• 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.

  PMID: 25271750 RESULT

• 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.

  PMID: 24726495 RESULT

• 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.

  PMID: 24724724 RESULT

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Linda Clark, RN

  Lungpacer Medical Inc.

  STUDY DIRECTOR

• Adrian Ebner, MD

  Italian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group assignment

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: September 6, 2018
• Study Start: May 7, 2018
• Primary Completion: June 30, 2018
• Study Completion: August 30, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)