Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Jun 22, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called non-invasive spinal cord stimulation to help patients with Acute Respiratory Distress Syndrome (ARDS) who need to be on a ventilator. The goal of the study is to see if this treatment can prevent muscle weakness in the respiratory muscles while the patients are on the ventilator. Researchers will recruit 20 participants in total: 10 who have had elective surgery and 10 who are suffering from ARDS. They will use a special device that sends gentle electrical signals to the spinal cord through surface electrodes placed on the skin.

To be eligible for this trial, participants must be between 18 and 85 years old, be intubated due to ARDS, and have certain intact physical and neurological functions. Patients will need to provide informed consent or have a family member do so on their behalf. Throughout the study, participants will receive spinal cord stimulation, and the researchers will monitor its safety and effectiveness. This trial is currently recruiting participants, and it is an important step in exploring potential new therapies for those facing serious respiratory challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female 18-85 years;
• • 2. 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;
• • 3. Able to provide informed consent or available next of kin able to provide informed consent;
• • 4. Have intact chest/lung, upper and lower extremity anatomy;
• • 5. The neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact;
• • 6. Enrollment of subject within 48 hours of intubation;
• • 7. Able to induce evoked response of diaphragm muscle by spinal cord TES.
• Exclusion Criteria:
• • 1. Phrenic nerve or diaphragm pacer;
• • 2. History of seizure disorder or on anti-epileptic medication for the treatment of seizures;
• • 3. Compromised skin in back (neck, upper and lower back);
• • 4. Pregnancy;
• • 5. Implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers;
• • 6. BMI greater than or equal to 35;
• • 7. Pharmacological paralysis/neuromuscular blockade\*.