Respiratory Distress Syndrome Clinical Trial
Official title:
Transcutaneous Spinal Cord Stimulation to Improve Respiratory Function and Shorten Ventilator Dependence in Patients With ARDS
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.
Stimulation will be conducted in closed-loop fashion at the start of inspiratory cycle. Signal from a chest belt will be used to synchronize stimulation with ventilator and prevent interference with ventilator (see Protection of Human Subjects). Prior to treatment stimulation, mapping will be conducted at 1 Hz with electrodes placed in locations identified to be optimal in the surgery cohort. Assessment of evoked EMG responses from respiratory muscles will be conducted. Once this electrode configuration is confirmed as effective (capable of evoking EMG activity), stimulation with this configuration will be applied for treatment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT06168149 -
The Relationship of Fetal Lung Elastography Values With the Development of Respiratory Distress in Cases of Preterm Labor
|
||
| Recruiting |
NCT03670732 -
CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure
|
N/A | |
| Recruiting |
NCT02901652 -
NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome
|
N/A | |
| Completed |
NCT02249143 -
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
|
N/A | |
| Suspended |
NCT01852916 -
NHFOV Versus NCPAP to Prevent Exubation Failure
|
N/A | |
| Completed |
NCT00208039 -
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
|
N/A | |
| Recruiting |
NCT03510169 -
Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe
|
N/A | |
| Completed |
NCT00004494 -
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
|
Phase 1 | |
| Completed |
NCT00006058 -
Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
|
N/A | |
| Completed |
NCT00004805 -
Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death
|
N/A | |
| Completed |
NCT03292562 -
A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation
|
N/A | |
| Completed |
NCT05948332 -
Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
|
||
| Completed |
NCT05038514 -
The Effect of Music Therapy in COVID-19 Patients Given Prone Position
|
N/A | |
| Active, not recruiting |
NCT04079829 -
Postoperative Respiratory Abnormalities
|
||
| Completed |
NCT05462509 -
Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda
|
N/A | |
| Active, not recruiting |
NCT03808402 -
The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
|
||
| Completed |
NCT01812681 -
Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities
|
N/A | |
| Completed |
NCT01517958 -
Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates
|
N/A | |
| Not yet recruiting |
NCT01440868 -
Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome
|
N/A | |
| Completed |
NCT01222247 -
Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
|
Phase 3 |