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

Ventilator Induced Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670460
• Other study ID #: TPR-0046 and CLN-0005
• Status: Completed
• Phase: N/A
• First received: January 27, 2016
• Last updated: April 14, 2016
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Lungpacer Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Paraguay: Ministerio de Salud Pública y Bienestar Social
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lung Injury
• Ventilator Induced Lung Injury
• Ventilator-Induced Lung Injury

Intervention

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.

Locations

Country	Name	City	State
Paraguay	Italian Hospital	Asuncion	Casa Zanotti

Sponsors (1)

Lead Sponsor	Collaborator
Lungpacer Medical Inc.

Country where clinical trial is conducted

Paraguay, 

References & Publications (4)

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. — View Citation

Peñuelas O, Frutos-Vivar F, Fernández C, Anzueto A, Epstein SK, Apezteguía C, González 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. — View Citation

Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. Review. Erratum in: N Engl J Med. 2014 Apr 24;370(17):1668-9. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes