Actively Recruiting

Phase Not Applicable
All Genders
ID06572280

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

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult ARDS patients undergoing controlled mechanical ventilation
  • Duration of endotracheal intubation less than 48 hours
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

Post-operative Follow-up

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

Loading map...

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

Similar Trials

Lung Barometric Measurements in Normal And in Respiratory Di...

Ventilator-Induced Lung Injury

Actively Recruiting

1 location

A Pilot Study of a New Ultrasonographic Tool to Assess Regio...

Mechanical Ventilation Complication

Actively Recruiting

1 location

Alveolar Macrophage Programming Following Endotoxin Exposure

ARDS, Human

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here