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

Randomized Study of TransAeris® System for Enhanced Recovery After Surgery (ERAS) in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Ventilator Induced Diaphragm Dysfunction
• Intervention / Treatment: Device: TransAeris

Detailed Description

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
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeff Thompson; Phone Number: 121 440-774-2488; Email: jthompson@synapsebiomedical.com
• Study Contact Backup: Name: Anthony Ignagni; Phone Number: 110 440-774-2488; Email: aignagni@synapsebiomedical.com

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control / Crossover to TransAeris Therapy; 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.	Device: TransAeris; 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.
Experimental: Treatment with TransAeris Therapy; 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.	Device: TransAeris; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects experiencing serious device-related adverse effects	All participants will be assessed for serious device-related adverse effects	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	90 days after study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects experiencing device-related adverse events	All participants will be assessed for device-related adverse events	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	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	90 days after study completion

Collaborators and Investigators

• Sponsor: Synapse Biomedical
• Investigators: Principal Investigator: Raymond P Onders, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: VIDD
• Other Study ID Numbers: 20-1000-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes