Effect of Early Non-invasive Phrenic Nerve Stimulation on Weaning in Mechanically Ventilated Patients：A Multicenter, Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Ventilator-free days
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
Patients enrolled in the study were unaware of the study
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
conventional group
- conventional respiratory therapy and pulmonary rehabilitation, including airway management, early activity, and respiratory muscle training.
- No intervention
PNS group
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.
Intervention: Non-invasive phrenic nerve stimulation (Device)
Outcomes
Primary Outcomes
Ventilator-free days
Time Frame: 28 days
Secondary Outcomes
- Transdiaphragmatic Pressure(up to 28 days)
- re-intubation rate(28 days)
- ICU mortality(28 days)
- diaphragm thickening fraction(up to 28 days)
- Diaphragm thickness(up to 28 days)
- mechanical ventilation days(28 days)
- Maximal Inspiratory Pressure(up to 28 days)
- 60/90-day survival rate(28 days)
Investigators
Bing Sun
professor of treatment
Beijing Chao Yang Hospital