Using non-invasive phrenic nerve stimulation to help wean patients off mechanical ventilation

Effect of Early Non-invasive Phrenic Nerve Stimulation on Weaning in Mechanically Ventilated Patients：A Multicenter, Randomized Controlled Study

This study is testing if a new non-invasive treatment using phrenic nerve stimulation can help patients on mechanical ventilation breathe on their own sooner and strengthen their breathing muscles.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Chao Yang Hospital (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05629819 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of early non-invasive phrenic nerve stimulation (PNS) on patients who are mechanically ventilated. It involves a prospective randomized controlled design with 104 participants, who are divided into two groups: one receiving PNS alongside standard care and the other receiving conventional treatment. The aim is to assess whether PNS can increase the number of days patients can spend off mechanical ventilation, delay diaphragm atrophy, and enhance inspiratory muscle strength over a 28-day period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have been on mechanical ventilation for less than 48 hours but are expected to require it for at least 72 hours.

Not a fit: Patients with contraindications to phrenic nerve stimulation, neuromuscular diseases, or those in end-stage or palliative care may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the duration of mechanical ventilation for patients, leading to improved recovery outcomes.

How similar studies have performed: While the approach of using phrenic nerve stimulation is promising, it is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

* Age ≥18years and ≤80years;
* MV time ≤48h;
* MV duration is expected to be ≥72h;
* The sternocleidomastoid region and pectoralis major region were completely exposed.
* Patients or family members are willing to sign informed consent and participate in the study.

Exclusion Criteria:

* There are contraindications to PNS in vitro (Pneumothorax, active tuberculosis, pleural adhesions, installation of pacemakers and defibrillators, etc.);
* Neuromuscular disease (myasthenia gravis, etc.) or known anatomical abnormalities of the diaphragm;
* ECMO status;
* Hemodynamic instability;
* Uncorrected arrhythmias;
* Be pregnant;
* Clinical end-stage and palliative care patients.

Where this trial is running

Beijing, Beijing

• Bing Sun — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Bing Sun, MD — Beijing Chao Yang Hospital
• Study coordinator: Li Wang, B.S.Nurs

Conditions: Mechanical Ventilation, Weaning, phrenic nerve stimulation, diaphragm function