Using spinal cord stimulation to reduce ventilator dependence in ARDS patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and feasibility of non-invasive spinal cord stimulation to prevent respiratory muscle atrophy in patients with Acute Respiratory Distress Syndrome (ARDS) who are on mechanical ventilation. The study will recruit 20 participants, including 10 elective surgery patients and 10 ARDS patients, using a prototype stimulator with hydrogel electrodes to stimulate the spinal cord. Stimulation will be synchronized with the ventilator to ensure effective treatment while avoiding interference. The trial aims to assess the evoked EMG responses from respiratory muscles to confirm the effectiveness of the stimulation configuration before applying it for treatment.

Why it matters

Who can join: the full rules

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\*.

Where it's running

• University of California, Los Angeles
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Daniel Lu, MD, PhD — University of California, Los Angeles
• Study coordinator: Daniel Lu, MD, PhD
• Email: dclu@mednet.ucla.edu
• Phone: 310-825-4321

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Caffeine in pregnancy: how the mother and baby handle it during delivery

  This study tests how caffeine is processed in pregnant people and how much reaches the baby when given shortly before delivery.

  Recruiting Phase 1 Indiana University · Indianapolis, Indiana · NCT07570121

• L-carnitine for preterm babies with respiratory distress syndrome

  This will see if giving L-carnitine to preterm babies with respiratory distress helps them gain weight, leave the hospital sooner, or survive the early newborn period.

  Recruiting RESnTEC, Institute of Research · Muzaffargarh, Punjab Province · NCT07437391

• Serum endocan and copeptin levels in preterm babies with respiratory distress

  This will test whether blood levels of endocan and copeptin on the first day of life are linked to how severe respiratory distress is in preterm newborns (28–36 weeks).

  Recruiting Tanta University · Tanta, El-Gharbia · NCT07154134

• Impact of elective cesarean sections on newborn respiratory distress

  This study looks at whether having an elective cesarean section affects the chances of newborns having breathing problems, specifically for pregnant women aged 20-39 who are at least 37 weeks along and have received treatment to help their baby's lungs.

  Recruiting Assiut University · Asyut · NCT06874478

• Lung and heart ultrasound for acute breathlessness in older adults

  This project will test whether using bedside lung and heart ultrasound helps doctors quickly find the cause and give the right treatment for sudden breathlessness in people over 65.

  Recruiting University Hospital, Toulouse · Toulouse · NCT06807983

• APC-0101 with noninvasive breathing support for preterm infants with respiratory distress syndrome

  This will test whether inhaled APC-0101 given with nCPAP/NIV helps preterm infants with respiratory distress syndrome breathe better than nCPAP/NIV alone.

  Recruiting at 30 sites Phase 3 Aerogen Pharma Limited · Little Rock, Arkansas and 30 other locations · NCT06776783

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.