The Impact Of Respiratory Neuromuscular Stimulation On Patients With Invasive Mechanical Ventilation

April 28, 2025 updated by: Jian-Xin Zhou, Capital Medical University

The Impact Of Respiratory Neuromuscular Stimulation On Patients With Invasive Mechanical Ventilation: A Prospective Randomized Crossover Physiological Study

Mechanical ventilation (MV) is an important treatment measure for critically ill patients in the intensive care unit (ICU). MV is widely used in the treatment of respiratory failure and is also one of the important means of life support for critically ill patients after surgery. Although the use of MV has significantly reduced the mortality rate of critically ill patients, MV is also a double-edged sword. A large amount of evidence shows that it can lead to complications such as ventilator-induced diaphragmatic dysfunction (VIDD) . In a retrospective study, it was first found and proposed that long-term MV can lead to diaphragmatic atrophy. Later, a prospective clinical study conducted by Le Bourdelles et al. provided direct evidence to support this conjecture. Continuous use of mechanical ventilation for 48 hours can cause diaphragmatic atrophy and contractile dysfunction. Therefore, effectively preventing diaphragmatic atrophy is of great significance for the outcome of patients with mechanical ventilation.

Respiratory NMES has been used in clinical practice for decades. Previous studies have shown that electrical stimulation of a certain intensity applied to the respiratory neuromuscular can increase the excitability of the phrenic nerve, enhance diaphragmatic contraction, increase the range of diaphragmatic movement, and improve lung ventilation. In addition to the diaphragm, the abdominal muscles are also an important part of the respiratory muscles and an important supplement to the inspiratory muscles. Studies have shown that electrical stimulation of the abdominal muscles can retrain the expiratory muscles, increase muscle strength, induce expiratory muscle contraction through repeated afferent stimulation of the abdominal muscles, increase intra-abdominal pressure, facilitate the upward movement of the diaphragm, reduce thoracic pressure and lung volume, and thus improve the ability of expiration and expectoration. Electrical stimulation of the abdominal muscles has received increasing attention as a supplement to inspiratory muscle training, and many foreign literatures have reported on the improvement of respiratory function by abdominal muscle stimulation. At present, some domestic scholars have also reported that simultaneous stimulation of the phrenic nerve and abdominal muscles can improve the quality of life and prognosis of patients. However, there are few studies on how simultaneous stimulation of the diaphragm and abdominal muscles can improve the physiological effect indicators of the respiratory system, especially the impact on respiratory drive and inspiratory effort. Animal model studies have shown that electrical stimulation of the phrenic nerve in rabbits can significantly reduce the central drive of the diaphragm and the conduction function of the phrenic nerve after diaphragmatic fatigue, and the reduction of central drive may be a self-protective mechanism of the body. An observational study abroad suggested that percutaneous diaphragmatic electrical stimulation can control WOB within four-fifths of the normal range 96.8% of the time. This study is dedicated to applying respiratory NMES to study the impact on the physiological parameters of patients with invasive mechanical ventilation, providing a theoretical basis for its clinical application in critically ill patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged between 18 and 80 years;
  2. Mechanical ventilation duration > 48 hours;
  3. Hemodynamically stable;
  4. RASS score ranging from 1 to -2.

Exclusion Criteria:

  1. Having a pacemaker implanted;
  2. Unhealed surgical wounds in the chest or abdomen;
  3. Pregnant women and lactating women;
  4. History of recent airway surgery or trauma;
  5. Surgery in the neck, chest, or upper abdomen;
  6. Intracranial hypertension;
  7. Contraindications for esophageal pressure catheter placement;
  8. Withdrawal of life support.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phrenic nerve stimulation (PNS) at 8mA
Phrenic nerve stimulation is applied at 8mA.
Procedure: Phrenic nerve stimulation at 8mA
Phrenic nerve stimulation (PNS) at 8mA is applied.
Experimental: Phrenic nerve stimulation (PNS) at 15mA
Phrenic nerve stimulation is applied at 15mA
Procedure: Phrenic nerve stimulation at 15mA
Phrenic nerve stimulation (PNS) at 15mA is applied.
Experimental: Phrenic nerve stimulation (PNS) at 15mA combined with phrenic-abdominal stimulation at 15mA
Phrenic nerve stimulation (PNS) at 15mA combined with phrenic-abdominal stimulation at 15mA is applied.
Procedure: Phrenic nerve stimulation at 15mA combined with phrenic-abdominal stimulation at 15mA
Phrenic nerve stimulation (PNS) at 15mA combined with phrenic-abdominal stimulation at 15mA is applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tidal swing of esophageal pressure
Time Frame: From enrollment to the end of treatment at 4 hours
Tidal swing of esophageal pressure will be measured
From enrollment to the end of treatment at 4 hours
Esophageal pressure-time product
Time Frame: From enrollment to the end of treatment at 4 hours
Esophageal pressure-time product will be measured.
From enrollment to the end of treatment at 4 hours
Inspiratory muscle pressure
Time Frame: From enrollment to the end of treatment at 4 hours
Inspiratory muscle pressure will be measured.
From enrollment to the end of treatment at 4 hours
Dynamic transpulmonary pressure
Time Frame: From enrollment to the end of treatment at 4 hours
Dynamic transpulmonary pressure will be measured.
From enrollment to the end of treatment at 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory rate
Time Frame: From enrollment to the end of treatment at 4 hours
Respiratory rate will be measured.
From enrollment to the end of treatment at 4 hours
Tidal volume
Time Frame: From enrollment to the end of treatment at 4 hours
Tidal volume will be measured.
From enrollment to the end of treatment at 4 hours
Heart rate
Time Frame: From enrollment to the end of treatment at 4 hours
Heart rate will be measured.
From enrollment to the end of treatment at 4 hours
Mean blood pressure
Time Frame: From enrollment to the end of treatment at 4 hours
Mean blood pressure will be measured.
From enrollment to the end of treatment at 4 hours
Critical care pain observation tool (CPOT) scale
Time Frame: From enrollment to the end of treatment at 4 hours
Critical care pain observation tool (CPOT) scale will be measured
From enrollment to the end of treatment at 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IIT2024-099-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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