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TransAeris System for Prolonged Mechanical Ventilation Complications (ERAS Trial)

N/A

Waitlist Available

Led By Raymond P Onders, MD

Research Sponsored by Synapse Biomedical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is undergoing an open cardiac procedure by median sternotomy

Subject is at risk of prolonged mechanical ventilation if meeting 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days after implantation

Awards & highlights

ERAS Trial Summary

This trial will test a new system to prevent or treat a common complication of mechanical ventilation.

Who is the study for?

This trial is for adults aged 22 or older who are undergoing open heart surgery and are at risk of needing a ventilator for an extended time due to factors like previous heart surgeries, weak heart pumping function, stroke history, planned use of certain heart support devices during surgery, or chronic lung disease. Pregnant women and those with conditions affecting the diaphragm or involved in other studies that could influence results can't participate.Check my eligibility

What is being tested?

The TransAeris system is being tested to see if it can prevent or treat muscle weakness caused by long-term use of a ventilator after open-heart surgery. Participants will be randomly assigned to either receive this new treatment or not as part of their post-surgery care.See study design

What are the potential side effects?

Potential side effects related to the TransAeris system may include discomfort at the site where it's used, possible injury to surrounding tissues or organs from its placement and operation, and general risks associated with medical device usage.

ERAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having open-heart surgery through a chest bone cut.

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I am at risk of needing a ventilator for a long time due to my heart or lung condition.

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I am at least 22 years old.

ERAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days after implantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days after implantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days after implantation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of subjects experiencing serious device-related adverse effects

Proportion of subjects weaned at 48 hours and 120 hours

Secondary outcome measures

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

Average number of days in the hospital

Number of subjects experiencing device-related adverse events

ERAS Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment with TransAeris TherapyExperimental Treatment1 Intervention

The "Treatment" group will start TranAeris therapy shortly after arrival in the Intensive Care Unit (ICU). Participants will use the study device in the ICU until liberated from the ventilator but no longer than 30 days after implant surgery.

Group II: Control / Crossover to TransAeris TherapyExperimental Treatment1 Intervention

The "Control" group will be treated per standard hospital policy following electrode implant. If the participant is not liberated from mechanical ventilation after 120 hours (5 days), the participant will begin using TransAeris therapy. The participant will use the study device in the ICU until liberated from the ventilator but no longer than 30 days after implant surgery.

0 / 3Eligibility criteria met