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

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629819
• Other study ID #: PNS in MV patients
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Beijing Chao Yang Hospital
• Contact: Li Wang, B.S.Nurs
• Phone: 86015910268323
• Email: mu0mu0[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mechanical Ventilation
• Weaning

Intervention

Device:
• Non-invasive phrenic nerve stimulation
Some studies have shown that PNS can relieve diaphragmatic atrophy and reverse diaphragmatic dysfunction.

Locations

Country	Name	City	State
China	Bing Sun	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Bing Sun

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of adverse events		up to 28 days
Other	Medical expenses		through study completion, an average of 30 days
Primary	Ventilator-free days		28 days
Secondary	mechanical ventilation days		28 days
Secondary	re-intubation rate		28 days
Secondary	ICU mortality		28 days
Secondary	60/90-day survival rate		28 days
Secondary	Maximal Inspiratory Pressure		up to 28 days
Secondary	Diaphragm thickness		up to 28 days
Secondary	diaphragm thickening fraction		up to 28 days
Secondary	Transdiaphragmatic Pressure		up to 28 days