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

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Induced Lung Injury
• Intervention / Treatment: Device: LIVE Catheter

Detailed Description

This study is being conducted to determine if in an anaesthetized (sedated, intubated and mechanically ventilated) subject the LIVE Catheter can be inserted percutaneously and activated via the electrical stimulator to stimulate the left and right phrenic nerves causing the diaphragm to contract in synchrony with mechanical ventilator breaths via phrenic nerve stimulation from a transvenously delivered electrical current.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Casa Zanotti
    • Asuncion, Casa Zanotti, Paraguay
      • Italian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Temporary diaphragmatic pacing; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phrenic nerve stimulation in synchrony with MV breaths	Phrenic nerve stimulation in synchrony with MV breaths as defined by contraction of the diaphragm upon energy delivery.	No more than 90 minutes procedure duration

Collaborators and Investigators

• Sponsor: Lungpacer Medical Inc.
• Investigators: Study Director: Steve Reynolds, MD, Lungpacer Medical

Publications and helpful links

General Publications

• 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. Erratum In: N Engl J Med. 2014 Apr 24;370(17):1668-9.
• 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.
• Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: TPR-0046 and CLN-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Discussing a publication for FIH