Effect of Early Non-invasive Phrenic Nerve Stimulation on Weaning in Mechanically Ventilated Patients

Study Overview
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Brief Summary
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the early application of non-invasive PNS in MV patients can increase the number of days without mechanical ventilation, delay disuse phrenic atrophy, and improve the strength of inspiratory muscle.

Detailed Description
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A prospective randomized controlled study included 104 patients with MV who met inclusion criteria in multiple hospital ICU units and were randomly divided 1:1 into PNS and conventional groups. The PNS group received neuromuscular electrical stimulation in addition to routine airway management, early activity and respiratory muscle training. It was verified that early non-invasive PNS could increase the number of days without mechanical ventilation for 28 days, delay disused diaphragm atrophy and improve inspiratory muscle strength.

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

Conditions
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Mechanical Ventilation, Weaning

Intervention / Treatment
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* Device: Non-invasive phrenic nerve stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PNS group<br>In addition to conventional respiratory therapy and pulmonary rehabilitation, neuromuscular electrical stimulator was used for PNS Device Settings Strength: Maximum current tolerated by the patient (0-100mA, commonly used below 13mA) ； Stimulation time: 1.0s; Frequency: 40Hz; Location: The stimulation electrodes were attached to the left and right sides of the neck under the outer margin of the sternocleidomastoid muscle 1/3; The reference electrodes were attached to the surface of both pectoralis major muscles. Treatment frequency: 30 at a time, Bid, until withdrawal/death/for 4 weeks. | Device: Non-invasive phrenic nerve stimulation<br>* Some studies have shown that PNS can relieve diaphragmatic atrophy and reverse diaphragmatic dysfunction.<br>|
| No Intervention: conventional group<br>conventional respiratory therapy and pulmonary rehabilitation, including airway management, early activity, and respiratory muscle training. No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-free days |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mechanical ventilation days |  | 28 days | 
| re-intubation rate |  | 28 days | 
| ICU mortality |  | 28 days | 
| 60/90-day survival rate |  | 28 days | 
| Maximal Inspiratory Pressure |  | up to 28 days | 
| Diaphragm thickness |  | up to 28 days | 
| diaphragm thickening fraction |  | up to 28 days | 
| Transdiaphragmatic Pressure |  | up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phrenic nerve stimulation, diaphragm function