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

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation; Weaning
• Intervention / Treatment: Device: Non-invasive phrenic nerve stimulation

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 Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bing Sun, MD; Phone Number: 86013911151075; Email: ricusunbing@126.com
• Study Contact Backup: Name: Li Wang, B.S.Nurs; Phone Number: 86015910268323; Email: mu0mu0@yeah.net

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Bing Sun
      • Contact: Bing Sun, MD; Phone Number: +8613911151075; Email: ricusunbing@126.com
      • Contact: Li Wang, B.S.Nurs; Phone Number: +8615910268323; Email: mu0mu0@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Non-invasive phrenic nerve stimulation; Some studies have shown that PNS can relieve diaphragmatic atrophy and reverse diaphragmatic dysfunction.
No Intervention: conventional group; conventional respiratory therapy and pulmonary rehabilitation, including airway management, early activity, and respiratory muscle training.; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ventilator-free days	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU mortality	28 days
mechanical ventilation days	28 days
re-intubation rate	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

Other Outcome Measures

Outcome Measure	Time Frame
The incidence of adverse events	up to 28 days
Medical expenses	through study completion, an average of 30 days

Collaborators and Investigators

• Sponsor: Bing Sun
• Investigators: Principal Investigator: Bing Sun, MD, Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: phrenic nerve stimulation; diaphragm function
• Other Study ID Numbers: PNS in MV patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No