Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles

About this trial

This is an early phase, proof-of-concept clinical trial assessing the safety and feasibility of non-invasive spinal cord stimulation to prevent respiratory muscle atrophy in mechanically ventilated ARDS patients. The investigators will recruit 10 elective surgery patients (surgery cohort) and 10 ARDS patients (ARDS cohort) for this study. A non-invasive, alpha-prototype Restore Technology stimulator using hydrogel surface electrodes will be used to stimulate the spinal cord at the cervical or thoracic level.

Eligibility criteria

Qualifiers

Male or female 18-85 years;

Intubated with confirmed diagnosis of ARDS (by Berlin Criteria: acute onset within one week of known insult, bilateral airspace opacities not fully explained by pleural effusions, atelectasis, and/or nodules, respiratory failure not explained by heart failure or fluid overload, PaO2/FiO2 ratio < 300); or identified as a patient admitted to the intensive care unit (ICU) after non-cardiac surgery;

Able to provide informed consent or available next of kin able to provide informed consent;

Have intact chest/lung, upper and lower extremity anatomy;

Disqualifiers

Phrenic nerve or diaphragm pacer;

History of seizure disorder or on anti-epileptic medication for the treatment of seizures;

Compromised skin in back (neck, upper and lower back);

Pregnancy;

Trial design

Treatments tested in this trial

  • Transcutaneous Biopac Electrical Stimulator

Treatment groups

20 Participants
are divided into 2 treatment groups