Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

Lungpacer Medical Inc.110 enrolled

Overview

A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have failed at least two weaning attempts. The goal is to strengthen and rehabilitate the diaphragm to liberate the patient more quickly from mechanical ventilation.

Mechanical ventilation (MV) is a life saving technology but can also cause damage to the lungs and diaphragm such as ventricular induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory MV and sedated the diaphragm begins to atrophy within as short as 18 hours. The Lungpacer Diaphragm Pacing Therapy System (DPTS) is a temporary therapy that consists of the Lungpacer IntraVenous Electrode Catheter (LIVE Catheter) and the Lungpacer Control Unit 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. The LIVE Catheter can also be used for fluid delivery like any other central venous catheter. The randomized clinical trial will investigate the safety, effectiveness and performance of the Lungpacer DPTS. By stimulating the diaphragm through daily therapy sessions, with the intention of exercising and rehabilitating the diaphragm muscle so the patient may be able to be more quickly liberated from MV. The patient population includes those who have been mechanically ventilated for greater than or equal to 96 hours (4days), have failed two or more spontaneous breathing trials (SBT), and were not hypervolemic during the latest spontaneous breathing trial. Patients must have resolution of the initial indication for placement on mechanical ventilation before entering the trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

110

Conditions

Ventilator Induced Diaphragm Dysfunction

Interventions

Diaphragmatic Pacing Therapy DPTSDEVICE

Subjects will undergo DPTS 2 times a day until successfully extubated with no reintubation within 48 hours.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older * have been mechanically ventilated for \> or = to 96 hours (4 days), and * have satisfied the Readiness-to-Wean criteria and * have failed at least two VLTs, one of which is the study specific VLT. Exclusion Criteria: * currently on extracorporeal membrane oxygenation (ECMO); * weaning failure due to hypervolemia; * medical history or known anatomy that prevents insertion of the LIVE Catheter into the left subclavian vein; * currently being treated with neuromuscular blockade; * clinically overt congestive heart failure that is preventing weaning; * pre-existing neuromuscular diseases that could affect the respiratory muscles; * pre-existing severe chronic pulmonary fibrosis; * pleural effusions occupying greater than one third of the pleural space on either side; * BMI \> or = 40; * known or suspected phrenic nerve paralysis; * any electrical device (implanted or external) that may be prone to interaction with or interference from the Lungpacer DPTS including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators; * prior bacteremia reported within the last 48 hours; * current hemodynamic instability, sepsis or septic shock; * terminally ill with 6 months or less life expectancy or not committed to full care; * known or suspected to be pregnant or lactating; and * currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.

Locations (21)

CHU Angers, Reanimation Medicale

Angers, France

Hopital Louis-Mourier

Colombes, France

Outcomes

Primary Outcomes

Proportion successfully weaned by 30 days for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control.

"Successfully weaned" is defined as passing the protocol-specific Ventilator Liberation Trial (VLT), or removed from MV, and not reintubated (subjects with an oral or nasal, endotracheal tube) or returned to MV (subjects with a tracheostomy) within 48 hours

Time frame: Patients will be allowed to stay in the study for up to 30 (+2 days of follow up for adverse events) days if not removed from mechanical ventilation sooner

Secondary Outcomes

Days on mechanical ventilation

Days on mechanical ventilation from randomization to removal from MV associated with successful weaning or Day 30, whichever comes first

Time frame: from randomization to 30 days

Changes in diaphragmatic thickening fraction on diaphragm ultrasound

Evaluate difference in changes in diaphragmatic thickening fraction between study allocation groups from randomization to successful weaning or on day 30 whichever comes first;

Time frame: to successful weaning or on day 30 which ever comes first.

Changes in MIP

Change in MIP from randomization to last available measure; Change in MIP over time from randomization (baseline).

Time frame: to successful weaning, or on day 30, whichever comes first.

Change in MIP

Rate of MIP change per day from randomization (baseline) to last available measure;

Time frame: to successful weaning, or on day 30 whichever comes first.

Changes in RSBI

Change in RSBI from randomization (baseline) to last available measure; Change in RSBI over time from randomization (baseline);

Data from ClinicalTrials.gov

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