NCT02670460

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Lungpacer Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Ventilator Induced Lung Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-02-01
• Last updated: 2016-04-15

Locations

1 site across 1 country: Paraguay