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

NCT05629819 | Recruiting DMC

• 1 other identifier: PNS in MV patients
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Weaning

Keywords

phrenic nerve stimulation; diaphragm function

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days

  28 days

Secondary Outcomes (8)

• mechanical ventilation days

  28 days

• re-intubation rate

  28 days

• ICU mortality

  28 days

• 60/90-day survival rate

  28 days

• Maximal Inspiratory Pressure

  up to 28 days

Other Outcomes (2)

• The incidence of adverse events

  up to 28 days

• Medical expenses

  through study completion, an average of 30 days

Study Arms (2)

PNS group

EXPERIMENTAL

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

conventional group

NO INTERVENTION

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

Interventions

Non-invasive phrenic nerve stimulation DEVICE

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

PNS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bing Sun: lead

Study Sites (1)

Bing Sun

Beijing, Beijing Municipality, 100020, China

RECRUITING

Study Officials

• Bing Sun, MD

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Wang, B.S.Nurs

CONTACT

86015910268323; mu0mu0@yeah.net

Bing Sun, MD

CONTACT

86013911151075; ricusunbing@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients enrolled in the study were unaware of the study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor of treatment

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 29, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

CN (1)