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

Ventilator Induced Diaphragm Dysfunction Clinical Trial

— ERAS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04899856
• Other study ID #: 20-1000-105
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: May 2024

Study information

• Verified date: August 2023
• Source: Synapse Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ventilator Induced Diaphragm Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Synapse Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects experiencing serious device-related adverse effects	All participants will be assessed for serious device-related adverse effects	60 days after implantation
Primary	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	Number of subjects experiencing device-related adverse events	All participants will be assessed for device-related adverse events	90 days after study completion
Secondary	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
Secondary	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