NCT03107949

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE1)

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Lungpacer Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An early feasibility study to investigate the safety and feasibility of the Lungpacer Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the diaphragm of patients who have been intubated and invasively mechanically ventilated for \> or = 7 days, have failed two or more spontaneous breathing trials (SBT), and were not hypervolemic during the latest SBT.

Detailed description

Mechanical ventilation (MV) is a life saving technology but can also cause damage to the lungs and diaphragm such as ventilator induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory MV and sedated the diaphragm begins to atrophy within as little as 18 hours. The DPTS is a temporary therapy that consists of the Lungpacer IntraVenous Electrode Catheter (LIVE Catheter) and the lungpacer Control Unit (LCU) system. The LIVE Catheter is a proprietary central venous catheter that incorporates pacing electrodes in strategic areas that align with the left and right phrenic nerves in order to stimulate the nerves to recruit the diaphragm. The LIVE Catheter can also be used for fluid delivery like any other central venous catheter. This early feasibility trial will investigate the safety and feasibility of the DPTS as a therapy to recondition and strengthen the diaphragm by stimulating the diaphragm through daily sessions so the patient may be more quickly liberated from MV. The patient population includes those who have been mechanically ventilated for \> or = to 7 days, have failed two or more SBTs, and were not hypervolemic during the latest SBT. Patients must have resolution of the initial indication for placement on MV before entering the trial.

Conditions

• Ventilator Induced Diaphragm Dysfunction

Interventions

Type	Name	Description
DEVICE	Lungpacer DPTS (Diaphragm Pacing Therapy System)	Lungpacer Diaphragm Pacing therapy (DPTS) will be conducted in daily sessions until the patient has been extubated or day 30 if not extubated.

Timeline

• Start date: 2017-06-20
• Primary completion: 2018-01-30
• Completion: 2018-02-18
• First posted: 2017-04-11
• Last updated: 2021-05-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study