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.
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;
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;
Parallel
Transcutaneous Biopac Electrical Stimulator
DeviceA transcutaneous electrical stimulator sends low levels of electrical current through surface hydrogel electrodes directly to the spinal cord to improve function.
Recording of significant stimulation-induced adverse events (AE)
Although unlikely, we will record and monitor the number of stimulation-induced adverse events per case and per cohort. Our goal is to have an overall AE rate of less than 10% per cohort.
Recording of total ventilation time
The total time that patient is ventilated will be recorded to determine if stimulation reduces total intubation time
Measurement of diaphragm thickness
Evidence of maintenance of diaphragm muscle thickness (in mm) by ultrasound
Assessment of diaphragm and respiratory muscle EMG amplitudes
EMG amplitudes of diaphragm and other muscles involved in respiration (intercostals, trapezius, abdominal) will be measured at a couple time points throughout the study period to determine if stimulation can maintain muscle response.
Measurement of respiratory pressure
Peak Inspiratory and Expiratory pressure measurements (in mm Hg) will be recorded from ventilation units to determine if stimulation maintains or improves respiratory airway pressure.
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