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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05629819
Enrollment
104
Registered
2022-11-29
Start date
2023-01-01
Completion date
2024-12-31
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation, Weaning

Keywords

phrenic nerve stimulation, diaphragm function

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.

Interventions

DEVICENon-invasive phrenic nerve stimulation

Some studies have shown that PNS can relieve diaphragmatic atrophy and reverse diaphragmatic dysfunction.

Sponsors

Bing Sun
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Patients enrolled in the study were unaware of the study

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frame
Ventilator-free days28 days

Secondary

MeasureTime frame
mechanical ventilation days28 days
re-intubation rate28 days
ICU mortality28 days
60/90-day survival rate28 days
diaphragm thickening fractionup to 28 days
Transdiaphragmatic Pressureup to 28 days
Maximal Inspiratory Pressureup to 28 days
Diaphragm thicknessup to 28 days

Other

MeasureTime frame
The incidence of adverse eventsup to 28 days
Medical expensesthrough study completion, an average of 30 days

Countries

China

Contacts

Primary ContactLi Wang, B.S.Nurs
mu0mu0@yeah.net86015910268323
Backup ContactBing Sun, MD
ricusunbing@126.com86013911151075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026