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

Bing Sun

Status: Enrolling

Conditions: Weaning; Mechanical Ventilation

Treatments: Device: Non-invasive phrenic nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05629819

PNS in MV patients

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

PNS group

Experimental group

Description:

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.

Treatment:

Device: Non-invasive phrenic nerve stimulation

conventional group

No Intervention group

Description:

* conventional respiratory therapy and pulmonary rehabilitation, including airway management, early activity, and respiratory muscle training. * No intervention