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

NCT04899856 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-18

No results posted yet for this study

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).

Conditions

  • Ventilator Induced Diaphragm Dysfunction

Interventions

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.

Sponsors & Collaborators

  • Synapse Biomedical

    lead INDUSTRY

Principal Investigators

  • Raymond P Onders, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-10
Primary Completion
2024-05-31
Completion
2024-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04899856 on ClinicalTrials.gov