Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial

NCT02670460 | Completed

• 1 other identifier: TPR-0046 and CLN-0005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Successful insertion of the LIVE Catheter into the left subclavian vien

  Confirmation by cinefluoroscopy of the insertion of the LIVE Catheter into the Left subclavian vein with the tip located in the superior vena cava

  at time of procedure

• Absence of device related or procedure related adverse events

  Assess subject AE status out to 48 hours post procedure

  up to 48 hours or at time of discharge whichever comes first

Secondary Outcomes (1)

• Phrenic nerve stimulation in synchrony with MV breaths

  No more than 90 minutes procedure duration

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 subclavian vein.

Device: LIVE Catheter

Interventions

LIVE Catheter DEVICE

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.

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:

• Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent.
• Able to undergo general anaesthesia (sedation, intubation and mechanical ventilation)
• Susceptible indication for atrial septal defect closure

You may not qualify if:

• Subject has an EF of \< 30%
• Subject has a co-morbid illness or life expectancy \< 2 years
• Subject has experienced an AMI 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 (4)

• Penuelas O, Frutos-Vivar F, Fernandez C, Anzueto A, Epstein SK, Apezteguia C, Gonzalez M, Nin N, Raymondos K, Tomicic V, Desmery P, Arabi Y, Pelosi P, Kuiper M, Jibaja M, Matamis D, Ferguson ND, Esteban A; Ventila Group. Characteristics and outcomes of ventilated patients according to time to liberation from mechanical ventilation. Am J Respir Crit Care Med. 2011 Aug 15;184(4):430-7. doi: 10.1164/rccm.201011-1887OC.

  PMID: 21616997 BACKGROUND

• Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.

  PMID: 24283226 BACKGROUND

• Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.

  PMID: 23786764 BACKGROUND

• Gayan-Ramirez G. Ventilator-induced diaphragm dysfunction: time for (contr)action! Eur Respir J. 2013 Jul;42(1):12-5. doi: 10.1183/09031936.00076513. No abstract available.

  PMID: 23813310 BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Steve Reynolds, MD

  Lungpacer Medical

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 1, 2016
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

PA (1)