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.
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
- Conditions the study is for
- Mechanical Ventilation, Neuromuscular Electrical Stimulation (NMES)
- 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.
Yang Liu contact
China1 site
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038
Yang Liu, 8610 6392 6666, liuyang3406@bjsjth.cn
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 group | Role | What they receive |
|---|---|---|
| Phrenic nerve stimulation (PNS) at 8mA | Experimental | Phrenic nerve stimulation is applied at 8mA. Receives: Procedure: Phrenic nerve stimulation at 8mA |
| Phrenic nerve stimulation (PNS) at 15mA | Experimental | Phrenic 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 15mA | Experimental | Phrenic 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.
Tidal swing of esophageal pressure
Tidal swing of esophageal pressure will be measured
Measured: From enrollment to the end of treatment at 4 hours
Esophageal pressure-time product
Esophageal pressure-time product will be measured.
Measured: From enrollment to the end of treatment at 4 hours
Inspiratory muscle pressure
Inspiratory muscle pressure will be measured.
Measured: From enrollment to the end of treatment at 4 hours
Dynamic transpulmonary pressure
Dynamic transpulmonary pressure will be measured.
Measured: From enrollment to the end of treatment at 4 hours
Secondary outcomes (5)
Respiratory rate
Respiratory rate will be measured.
Measured: From enrollment to the end of treatment at 4 hours
Tidal volume
Tidal volume will be measured.
Measured: From enrollment to the end of treatment at 4 hours
Heart rate
Heart rate will be measured.
Measured: From enrollment to the end of treatment at 4 hours
Mean blood pressure
Mean blood pressure will be measured.
Measured: From enrollment to the end of treatment at 4 hours
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.
- First posted30 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Respiratory Neuromuscular Stimulation On Patients With Invasive Mechanical Ventilation: A Prospective Randomized Crossover Physiological Study
- ClinicalTrials.gov ID
- NCT06952335
- Acronym / sponsor ID
- IIT2024-099-002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phrenic nerve stimulation (PNS) at 8mA | Experimental | Procedure: Phrenic nerve stimulation at 8mAPhrenic nerve stimulation is applied at 8mA. |
| Phrenic nerve stimulation (PNS) at 15mA | Experimental | Procedure: Phrenic nerve stimulation at 15mAPhrenic nerve stimulation is applied at 15mA |
| Phrenic nerve stimulation (PNS) at 15mA combined with phrenic-abdominal stimulation at 15mA | Experimental | Procedure: Phrenic nerve stimulation at 15mA combined with phrenic-abdominal stimulation at 15mAPhrenic nerve stimulation (PNS) at 15mA combined with phrenic-abdominal stimulation at 15mA is applied. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 80 years;
- Mechanical ventilation duration > 48 hours;
- Hemodynamically stable;
- RASS score ranging from 1 to -2.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phrenic nerve stimulation at 8mAPhrenic nerve stimulation (PNS) at 8mA is applied. | Procedure or surgery | Phrenic nerve stimulation (PNS) at 8mA |
| Phrenic nerve stimulation at 15mAPhrenic nerve stimulation (PNS) at 15mA is applied. | Procedure or surgery | Phrenic nerve stimulation (PNS) at 15mA |
| Phrenic nerve stimulation at 15mA combined with phrenic-abdominal stimulation at 15mAPhrenic nerve stimulation (PNS) at 15mA combined with phrenic-abdominal stimulation at 15mA is applied. | Procedure or surgery | Phrenic nerve stimulation (PNS) at 15mA combined with phrenic-abdominal stimulation at 15mA |
Primary outcome
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
Esophageal pressure-time product
Time frame: From enrollment to the end of treatment at 4 hours
Esophageal pressure-time product will be measured.
Inspiratory muscle pressure
Time frame: From enrollment to the end of treatment at 4 hours
Inspiratory muscle pressure will be measured.
Dynamic transpulmonary pressure
Time frame: From enrollment to the end of treatment at 4 hours
Dynamic transpulmonary pressure will be measured.
5 secondary outcomes
Respiratory rate
Time frame: From enrollment to the end of treatment at 4 hours
Tidal volume
Time frame: From enrollment to the end of treatment at 4 hours
Heart rate
Time frame: 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
Critical care pain observation tool (CPOT) scale
Time frame: From enrollment to the end of treatment at 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Liu contact
1 site in 1 country: see every site and its status.
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.