NCT06952335

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

Not yet recruiting NA Last updated 30 April 2025

What this trial tests

NA trial testing Phrenic nerve stimulation at 8mA in Mechanical Ventilation in 12 participants. Not yet recruiting.

Timeline

1 May 2025

Primary endpoint
1 August 2025

1 September 2025

Quick facts

Lead sponsor	Capital Medical University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 May 2025
Primary completion	1 August 2025
Estimated completion	1 September 2025
Sites	1 location across China

Drugs / interventions tested

• Phrenic nerve stimulation at 8mA
• Phrenic nerve stimulation at 15mA
• Phrenic nerve stimulation at 15mA combined with phrenic-abdominal stimulation at 15mA

Conditions studied

• Mechanical Ventilation — all drugs for Mechanical Ventilation →
• Neuromuscular Electrical Stimulation (NMES) — all drugs for Neuromuscular Electrical Stimulation (NMES) →

Sponsor

Capital Medical University

Who can join

Adults 18 to 80, any sex, with Mechanical Ventilation or Neuromuscular Electrical Stimulation (NMES). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.