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Mechanical VentilationNCT06952335

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

A study testing Phrenic nerve stimulation at 8mA, Phrenic nerve stimulation at 15mA and Phrenic nerve stimulation at 15mA combined with phrenic-abdominal stimulation at 15mA in people with Mechanical Ventilation and Neuromuscular Electrical Stimulation (NMES), run by Capital Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Phrenic nerve stimulation at 8mA, Phrenic nerve stimulation at 15mA and Phrenic nerve stimulation at 15mA combined with phrenic-abdominal stimulation at 15mA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
1 May 2025to 1 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Jian-Xin Zhou, Doctor contact

8610 6392 6666

zhoujx.cn@icloud.com

Yang Liu contact

liuyang3406@bjsjth.cn

China1 site
  • Beijing Shijitan Hospital

    Beijing, Beijing Municipality, 100038

    Yang Liu, 8610 6392 6666, liuyang3406@bjsjth.cn

Other trials in China

About this study

Official title: 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.

Being tested
Phrenic nerve stimulation at 8mA, Phrenic nerve stimulation at 15mA, Phrenic nerve stimulation at 15mA combined with phrenic-abdominal stimulation at 15mA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phrenic nerve stimulation at 8mAProcedure or surgery

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

  • Phrenic nerve stimulation at 15mAProcedure or surgery

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

  • Phrenic nerve stimulation at 15mA combined with phrenic-abdominal stimulation at 15mAProcedure or surgery

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

Study groups in NCT06952335
Study groupRoleWhat they receive
Phrenic nerve stimulation (PNS) at 8mAExperimentalPhrenic nerve stimulation is applied at 8mA.
Receives: Procedure: Phrenic nerve stimulation at 8mA
Phrenic nerve stimulation (PNS) at 15mAExperimentalPhrenic nerve stimulation is applied at 15mA
Receives: Procedure: Phrenic nerve stimulation at 15mA
Phrenic nerve stimulation (PNS) at 15mA combined with phrenic-abdominal stimulation at 15mAExperimentalPhrenic nerve stimulation (PNS) at 15mA combined with phrenic-abdominal stimulation at 15mA is applied.
Receives: Procedure: Phrenic nerve stimulation at 15mA combined with phrenic-abdominal stimulation at 15mA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tidal swing of esophageal pressure

    Tidal swing of esophageal pressure will be measured

    Measured: From enrollment to the end of treatment at 4 hours

  2. Esophageal pressure-time product

    Esophageal pressure-time product will be measured.

    Measured: From enrollment to the end of treatment at 4 hours

  3. Inspiratory muscle pressure

    Inspiratory muscle pressure will be measured.

    Measured: From enrollment to the end of treatment at 4 hours

  4. Dynamic transpulmonary pressure

    Dynamic transpulmonary pressure will be measured.

    Measured: From enrollment to the end of treatment at 4 hours

Secondary outcomes (5)
  1. Respiratory rate

    Respiratory rate will be measured.

    Measured: From enrollment to the end of treatment at 4 hours

  2. Tidal volume

    Tidal volume will be measured.

    Measured: From enrollment to the end of treatment at 4 hours

  3. Heart rate

    Heart rate will be measured.

    Measured: From enrollment to the end of treatment at 4 hours

  4. Mean blood pressure

    Mean blood pressure will be measured.

    Measured: From enrollment to the end of treatment at 4 hours

  5. Critical care pain observation tool (CPOT) scale

    Critical care pain observation tool (CPOT) scale will be measured

    Measured: From enrollment to the end of treatment at 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06952335
Sponsor's protocol ID
IIT2024-099-002
Status last verified
Aug 2024
First submitted
22 Apr 2025
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Phrenic nerve stimulation at 8mA, Phrenic nerve stimulation at 15mA and Phrenic nerve stimulation at 15mA combined with phrenic-abdominal stimulation at 15mA in people with Mechanical Ventilation and Neuromuscular Electrical Stimulation (NMES), run by Capital Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jian-Xin Zhou, Doctor (8610 6392 6666, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tidal swing of esophageal pressure (time frame: From enrollment to the end of treatment at 4 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.

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