Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation

Synapse Biomedical40 enrolled

Overview

This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of prolonged mechanical ventilation (PMV).

This study is an open label, randomized, cross-over study in adult open cardiac surgery patients. All subjects will receive TransLoc electrodes at the time of open sternotomy cardiac procedure. Half of subjects will have TransAeris turned on upon entry to ICU, the other half will receive standard of care with TransAeris turned on if still intubated on mechanical ventilation after 120 hours.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ventilator Induced Diaphragm Dysfunction

Interventions

TransAerisDEVICE

TransAeris is used to provide neuromuscular electrical stimulation to the diaphragm while the patient is on mechanical ventilation to prevent, slow, or reverse diaphragm disuse atrophy and, more generally, to prevent and treat VIDD.

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is undergoing an open cardiac procedure by median sternotomy 2. Subject is at risk of prolonged mechanical ventilation according to one or more of the following criteria: * Prior open cardiac surgery * Left Ventricular Ejection Fraction (LVEF) ≤ 30% * History of TIA or CVA * Pre-operative or anticipated intraoperative intra-aortic balloon pump * History of COPD 3. Subject is at least 22 years of age 4. Informed consent has been obtained from the patient Exclusion Criteria: 1. Subject is on invasive mechanical ventilation prior to procedure 2. Subject has known or pre-existing phrenic nerve paralysis 3. Subject is having a left ventricular assist device implanted 4. Subject has progressive, non-reversible neuromuscular disease affecting the diaphragm 5. Subject is pregnant or lactating 6. Subject is actively participating in another clinical study which could affect outcomes in this study

Locations (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Number of subjects experiencing serious device-related adverse effects

All participants will be assessed for serious device-related adverse effects

Time frame: 60 days after implantation

Proportion of subjects weaned at 48 hours and 120 hours

Time on mechanical ventilation will be compared between the Control and Treatment groups

Time frame: 90 days after study completion

Secondary Outcomes

Number of subjects experiencing device-related adverse events

All participants will be assessed for device-related adverse events

Time frame: 90 days after study completion

Average number of days in the Intensive Care Unit (ICU)

Time in the ICU will be tracked for all study participants and averaged

Time frame: 90 days after study completion

Average number of days in the hospital

Time in the hospital will be tracked for all study participants and averaged

Time frame: 90 days after study completion

Data from ClinicalTrials.gov

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