Actively Recruiting
Non-invasive Phrenic Nerve Stimulation in ARDS Patients - a Feasibility Study
Led by Southeast University, China · Updated on 2024-08-27
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Reduced diaphragmatic activity during mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) can cause diaphragm weakening, lung collapse, increased lung stress, and blood flow problems. These issues may extend the time on ventilators, complicate weaning, and raise mortality risk. Researchers are exploring whether synchronized phrenic nerve stimulation can help maintain diaphragm function, prevent ventilator-related injuries, and improve outcomes. While implanted phrenic nerve stimulation is used in some neurological disorders, its effects in ARDS patients on mechanical ventilation need further study. The study evaluates a non-invasive device that delivers electrical stimulation to the phrenic nerve in ARDS patients on mechanical ventilation. This stimulation is synchronized to encourage diaphragm activity during ventilation. The intervention aims to reduce ventilator-induced lung and diaphragm damage. Patients receive this non-invasive phrenic nerve stimulation while undergoing usual mechanical ventilation care throughout the treatment period. Participants will be monitored from enrollment until extubation, with researchers measuring how often adequate tidal volumes are achieved and how quickly the stimulation device is successfully applied. Additional assessments include diaphragm thickness and movement, maximal inspiratory pressure, lung ventilation distribution, driving pressure, and respiratory system compliance. Safety and feasibility data will be collected to understand how this approach affects patient breathing and diaphragm function during ventilated support.
CONDITIONS
Brief Title
Non-invasive Phrenic Nerve Stimulation in ARDS Patient
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult ARDS patients undergoing controlled mechanical ventilation
- Duration of endotracheal intubation less than 48 hours
You will not qualify if you...
- Neurological conditions affecting motor neurons or muscles (e.g., ALS)
- Paralysis of the phrenic nerve
- Proven or suspected spinal cord injury
- Conditions limiting diaphragm movement
- Implanted cardiac support systems (pacemaker, implanted defibrillator)
- Implanted medical pumps
- Pregnancy
- Skin lesions, infections, or strictures in throat/neck area
- Metallic implants
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment until extubation
Participants receive non-invasive phrenic nerve stimulation while undergoing mechanical ventilation to promote diaphragmatic activity and prevent ventilator-induced complications.
Daily assessments during mechanical ventilation
Duration - Up to 28 days after extubation
Participants are monitored for diaphragm function and respiratory parameters following the intervention for up to 28 days.
Regular visits for up to 28 days
Trial Site Locations
Total: 1 location
1
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
L
ling liu, phD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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