Clinical trial NCT04899856: Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation
Official title: Randomized Study of TransAeris® System for Enhanced Recovery After Surgery (ERAS) in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ventilator Induced Diaphragm Dysfunction
Keywords: VIDD
Lead sponsor: Synapse Biomedical
Sponsor class: INDUSTRY
First posted: 2021-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model 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.
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects experiencing serious device-related adverse effects
timeFrame: 60 days after implantation
measure: Proportion of subjects weaned at 48 hours and 120 hours
timeFrame: 90 days after study completion
Secondary outcomes:
measure: Number of subjects experiencing device-related adverse events
timeFrame: 90 days after study completion
measure: Average number of days in the Intensive Care Unit (ICU)
timeFrame: 90 days after study completion
measure: Average number of days in the hospital
timeFrame: 90 days after study completion
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Raymond P Onders, MD
role: PRINCIPAL_INVESTIGATOR
References: