Mechanical VentilationNCT05629819
Effect of Early Non-invasive Phrenic Nerve Stimulation on Weaning in Mechanically Ventilated Patients
A study testing Non-invasive phrenic nerve stimulation in people with Mechanical Ventilation and Weaning, run by Bing Sun at 1 site in China.
Trial summary
the early application of non-invasive PNS in MV patients can increase the number of days without mechanical ventilation, delay disuse phrenic atrophy, and improve the strength of inspiratory muscle. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation, Weaning
- What is being tested?
- Non-invasive phrenic nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- 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
- Age ≥18years and ≤80years;
- MV time ≤48h;
- MV duration is expected to be ≥72h;
- The sternocleidomastoid region and pectoralis major region were completely exposed.
- Patients or family members are willing to sign informed consent and participate in the study.
Who cannot join
- There are contraindications to PNS in vitro (Pneumothorax, active tuberculosis, pleural adhesions, installation of pacemakers and defibrillators, etc.);
- Neuromuscular disease (myasthenia gravis, etc.) or known anatomical abnormalities of the diaphragm;
- ECMO status;
- Hemodynamic instability;
- Uncorrected arrhythmias;
- Be pregnant;
- Clinical end-stage and palliative care patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Bing Sun
Beijing, Beijing Municipality, 100020
Bing Sun, MD, +8613911151075, ricusunbing@126.com
Li Wang, B.S.Nurs, +8615910268323, mu0mu0@yeah.net
About this study
Official title: Effect of Early Non-invasive Phrenic Nerve Stimulation on Weaning in Mechanically Ventilated Patients：A Multicenter, Randomized Controlled Study
the early application of non-invasive PNS in MV patients can increase the number of days without mechanical ventilation, delay disuse phrenic atrophy, and improve the strength of inspiratory muscle.
Read the detailed description
A prospective randomized controlled study included 104 patients with MV who met inclusion criteria in multiple hospital ICU units and were randomly divided 1:1 into PNS and conventional groups. The PNS group received neuromuscular electrical stimulation in addition to routine airway management, early activity and respiratory muscle training. It was verified that early non-invasive PNS could increase the number of days without mechanical ventilation for 28 days, delay disused diaphragm atrophy and improve inspiratory muscle strength.
- Conditions
- Mechanical Ventilation, Weaning
- Being tested
- Non-invasive phrenic nerve stimulation
- Keywords
- phrenic nerve stimulation, diaphragm function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive phrenic nerve stimulationDevice
Some studies have shown that PNS can relieve diaphragmatic atrophy and reverse diaphragmatic dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| PNS group | Experimental | In addition to conventional respiratory therapy and pulmonary rehabilitation, neuromuscular electrical stimulator was used for PNS
* Device Settings Strength: Maximum current tolerated by the patient (0-100mA, commonly used below 13mA) ； Stimulation time: 1.0s; Frequency: 40Hz;
* Location: The stimulation electrodes were attached to the left and right sides of the neck under the outer margin of the sternocleidomastoid muscle 1/3; The reference electrodes were attached to the surface of both pectoralis major muscles.
* Treatment frequency: 30 at a time, Bid, until withdrawal/death/for 4 weeks. Receives: Device: Non-invasive phrenic nerve stimulation |
| conventional group | No intervention | * conventional respiratory therapy and pulmonary rehabilitation, including airway management, early activity, and respiratory muscle training. * No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days
Measured: 28 days
Secondary outcomes (8)
mechanical ventilation days
Measured: 28 days
re-intubation rate
Measured: 28 days
ICU mortality
Measured: 28 days
60/90-day survival rate
Measured: 28 days
Maximal Inspiratory Pressure
Measured: up to 28 days
Diaphragm thickness
Measured: up to 28 days
diaphragm thickening fraction
Measured: up to 28 days
Transdiaphragmatic Pressure
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bing Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bing Sun, Beijing Chao Yang Hospital
- Investigators
- Bing Sun, MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629819
- Sponsor's protocol ID
- PNS in MV patients
- Status last verified
- Mar 2024
- First submitted
- 11 Nov 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Non-invasive Phrenic Nerve Stimulation on Weaning in Mechanically Ventilated Patients：A Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05629819
- Acronym / sponsor ID
- PNS in MV patients
- Conditions
- Mechanical Ventilation, Weaning
- Keywords
- phrenic nerve stimulation, diaphragm function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Bing SunUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Nov 2022 (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.
the early application of non-invasive PNS in MV patients can increase the number of days without mechanical ventilation, delay disuse phrenic atrophy, and improve the strength of inspiratory muscle.
Detailed description
A prospective randomized controlled study included 104 patients with MV who met inclusion criteria in multiple hospital ICU units and were randomly divided 1:1 into PNS and conventional groups. The PNS group received neuromuscular electrical stimulation in addition to routine airway management, early activity and respiratory muscle training. It was verified that early non-invasive PNS could increase the number of days without mechanical ventilation for 28 days, delay disused diaphragm atrophy and improve inspiratory muscle strength.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNS group | Experimental | Device: Non-invasive phrenic nerve stimulationIn addition to conventional respiratory therapy and pulmonary rehabilitation, neuromuscular electrical stimulator was used for PNS * Device Settings Strength: Maximum current tolerated by the patient (0-100mA, commonly used below 13mA) ； Stimulation time: 1.0s; Frequency: 40Hz; * Location: The stimulation electrodes were attached to the left and right sides of the neck under the outer margin of the sternocleidomastoid muscle 1/3; The reference electrodes were attached to the surface of both pectoralis major muscles. * Treatment frequency: 30 at a time, Bid, until withdrawal/death/for 4 weeks. |
| conventional group | No intervention | –* conventional respiratory therapy and pulmonary rehabilitation, including airway management, early activity, and respiratory muscle training. * No intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18years and ≤80years;
- MV time ≤48h;
- MV duration is expected to be ≥72h;
- The sternocleidomastoid region and pectoralis major region were completely exposed.
- Patients or family members are willing to sign informed consent and participate in the study.
Key exclusion criteria (7 listed)
- There are contraindications to PNS in vitro (Pneumothorax, active tuberculosis, pleural adhesions, installation of pacemakers and defibrillators, etc.);
- Neuromuscular disease (myasthenia gravis, etc.) or known anatomical abnormalities of the diaphragm;
- ECMO status;
- Hemodynamic instability;
- Uncorrected arrhythmias;
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 |
|---|---|---|
| Non-invasive phrenic nerve stimulationSome studies have shown that PNS can relieve diaphragmatic atrophy and reverse diaphragmatic dysfunction. | Device | PNS group |
Primary outcome
Ventilator-free days
Time frame: 28 days
8 secondary outcomes
mechanical ventilation days
Time frame: 28 days
re-intubation rate
Time frame: 28 days
ICU mortality
Time frame: 28 days
60/90-day survival rate
Time frame: 28 days
Maximal Inspiratory Pressure
Time frame: up to 28 days
Diaphragm thickness
Time frame: up to 28 days
diaphragm thickening fraction
Time frame: up to 28 days
Transdiaphragmatic Pressure
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
Bing Sun, MD principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive phrenic nerve stimulation in people with Mechanical Ventilation and Weaning, run by Bing Sun 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 5 inclusion and 7 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 26 Mar 2024. 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 Li Wang, B.S.Nurs (86015910268323, mu0mu0@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days (time frame: 28 days). 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 26 Mar 2024.