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

NCT06952335 | Not Yet Recruiting DMC

• 1 other identifier: IIT2024-099-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation; Neuromuscular Electrical Stimulation (NMES)

Outcome Measures

Primary Outcomes (4)

• Tidal swing of esophageal pressure

  Tidal swing of esophageal pressure will be measured

  From enrollment to the end of treatment at 4 hours

• Esophageal pressure-time product

  Esophageal pressure-time product will be measured.

  From enrollment to the end of treatment at 4 hours

• Inspiratory muscle pressure

  Inspiratory muscle pressure will be measured.

  From enrollment to the end of treatment at 4 hours

• Dynamic transpulmonary pressure

  Dynamic transpulmonary pressure will be measured.

  From enrollment to the end of treatment at 4 hours

Secondary Outcomes (5)

• Respiratory rate

  From enrollment to the end of treatment at 4 hours

• Tidal volume

  From enrollment to the end of treatment at 4 hours

• Heart rate

  From enrollment to the end of treatment at 4 hours

• Mean blood pressure

  From enrollment to the end of treatment at 4 hours

• Critical care pain observation tool (CPOT) scale

  From enrollment to the end of treatment at 4 hours

Study Arms (3)

Phrenic nerve stimulation (PNS) at 8mA

EXPERIMENTAL

Phrenic nerve stimulation is applied at 8mA.

Procedure: Phrenic nerve stimulation at 8mA

Phrenic nerve stimulation (PNS) at 15mA

EXPERIMENTAL

Phrenic nerve stimulation is applied at 15mA

Procedure: Phrenic nerve stimulation at 15mA

Phrenic nerve stimulation (PNS) at 15mA combined with phrenic-abdominal stimulation at 15mA

EXPERIMENTAL

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

Interventions

Phrenic nerve stimulation at 8mA PROCEDURE

Phrenic nerve stimulation (PNS) at 8mA is applied.

Phrenic nerve stimulation (PNS) at 8mA

Phrenic nerve stimulation at 15mA PROCEDURE

Phrenic nerve stimulation (PNS) at 15mA is applied.

Phrenic nerve stimulation (PNS) at 15mA

Phrenic nerve stimulation at 15mA combined with phrenic-abdominal stimulation at 15mA PROCEDURE

Phrenic nerve stimulation (PNS) at 15mA combined with phrenic-abdominal stimulation at 15mA is applied.

Phrenic nerve stimulation (PNS) at 15mA combined with phrenic-abdominal stimulation at 15mA

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

Location

Central Study Contacts

Jian-Xin Zhou, Doctor

CONTACT

8610 6392 6666; zhoujx.cn@icloud.com

Yang Liu

CONTACT

liuyang3406@bjsjth.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Emergency and Critical Care Center

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: May 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 30, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)