Phrenic NerveNCT06491511
Repetitive Phrenic Nerve Stimulation in Critically Ill Patients Under Mechanical Ventilation
An observational study of Phrenic Nerve and Electrical Stimulation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Subjects: Patients aged 19 and older who are currently in the ICU and undergoing invasive mechanical ventilation. Methods: The study involves performing non-invasive repetitive phrenic nerve stimulation in ICU patients on mechanical ventilation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Phrenic Nerve, Electrical Stimulation
- What is being tested?
- Transcutaneous, repetitive phrenic nerve electrical stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jun 2024to 20 Sep 2024
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Adult patients aged 19 and older who are admitted to the ICU at Seoul National University Hospital on invasive mechanical ventilation for more than 48 hours
Who may be able to join
- Adult patients aged 19 and older who are admitted to the ICU at Seoul National University Hospital
- Patients receiving invasive mechanical ventilation (via endotracheal tube or tracheostomy)
- Patients who have been on invasive mechanical ventilation (via endotracheal tube or tracheostomy) for more than 48 hours
- Patients who have listened to and understood the explanation of the purpose and procedures of the study and have voluntarily agreed to participate. In cases where the patient has impaired consciousness or cognitive function and is unable to consent, the patient's legal representative has agreed to the patient's participation in the study.
Who cannot join
- Patients with implanted or externally applied electrical devices (such as pacemakers, defibrillators, implantable defibrillators, vagus nerve stimulators, spinal cord stimulators, gastric stimulators, diaphragm stimulators, etc.)
- Patients with a history of neck tumors, cervical spine instability, or neck surgery
- Patients with internal jugular vein catheters, infections, or inflammatory signs at the electrical stimulation site, making percutaneous phrenic nerve access impossible
- Patients with neurological or neuromuscular diseases that significantly affect respiratory muscle function
- Patients currently receiving neuromuscular blocking agents
- Patients already diagnosed with or suspected of having phrenic nerve paralysis
Show all 11Show fewer
- Patients with elevated hemidiaphragm observed on chest X-ray
- Patients with pleural effusion occupying more than one-third of the pleural space or pneumothorax requiring chest tube insertion, as seen on chest X-ray
- Patients who are confirmed or presumed to be pregnant
- Patients with a body mass index (BMI) ≥ 40
- Patients for whom life-sustaining treatment has been decided to be withdrawn and who have no plans for active treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Transcutaneous Repetitive Phrenic Nerve Stimulation Assessment in Critically Ill Patients Under Mechanical Ventilation - Pilot Study
Subjects: Patients aged 19 and older who are currently in the ICU and undergoing invasive mechanical ventilation.
Methods: The study involves performing non-invasive repetitive phrenic nerve stimulation in ICU patients on mechanical ventilation.
Stimulation protocol: The intensity and position of phrenic nerve stimulation were individualized. The frequency was set to 10Hz, 15Hz, and 20Hz. The duration of stimulation was adjusted according to the set inspiration time of mechanical ventilation.
- Conditions
- Phrenic Nerve, Electrical Stimulation
- Being tested
- Transcutaneous, repetitive phrenic nerve electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous, repetitive phrenic nerve electrical stimulationProcedure or surgery
Phrenic nerve electrical stimulation with different stimulation intensity and frequency
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | ICU patient with mechanical ventilator Receives: Procedure: Transcutaneous, repetitive phrenic nerve electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum diaphragm thickness during phrenic nerve repetitive stimulation
Maximum diaphragm thickness (mm)
Measured: Measured one time between 48 hours after intubation and before extubation.
Change in diaphragm thickness before and during phrenic nerve repetitive stimulation
Change of diaphragm thickness (mm)
Measured: Measured one time between 48 hours after intubation and before extubation.
Secondary outcomes (2)
Amplitude of the phrenic nerve compound motor action potential during phrenic nerve repetitive stimulation
CMAP amplitude (mV)
Measured: Measured one time between 48 hours after intubation and before extubation.
Area of the phrenic nerve compound motor action potential during phrenic nerve repetitive stimulation
CMAP area (ms*mV)
Measured: Measured one time between 48 hours after intubation and before extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start17 Jun 2024
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phrenic NerveStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Sung Eun Hyun, Seoul National University Hospital
- Investigators
- Sung Eun Hyun, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491511
- Sponsor's protocol ID
- 2312-166-1498
- Status last verified
- May 2025
- First submitted
- 14 Jun 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Transcutaneous Repetitive Phrenic Nerve Stimulation Assessment in Critically Ill Patients Under Mechanical Ventilation - Pilot Study
- ClinicalTrials.gov ID
- NCT06491511
- Acronym / sponsor ID
- 2312-166-1498
- Conditions
- Phrenic Nerve, Electrical Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 9 Jul 2024 (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.
Subjects: Patients aged 19 and older who are currently in the ICU and undergoing invasive mechanical ventilation.
Methods: The study involves performing non-invasive repetitive phrenic nerve stimulation in ICU patients on mechanical ventilation.
Stimulation protocol: The intensity and position of phrenic nerve stimulation were individualized. The frequency was set to 10Hz, 15Hz, and 20Hz. The duration of stimulation was adjusted according to the set inspiration time of mechanical ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Procedure: Transcutaneous, repetitive phrenic nerve electrical stimulationICU patient with mechanical ventilator |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Adult patients aged 19 and older who are admitted to the ICU at Seoul National University Hospital on invasive mechanical ventilation for more than 48 hours
Key inclusion criteria (4 listed)
- Adult patients aged 19 and older who are admitted to the ICU at Seoul National University Hospital
- Patients receiving invasive mechanical ventilation (via endotracheal tube or tracheostomy)
- Patients who have been on invasive mechanical ventilation (via endotracheal tube or tracheostomy) for more than 48 hours
- Patients who have listened to and understood the explanation of the purpose and procedures of the study and have voluntarily agreed to participate. In cases where the patient has impaired consciousness or cognitive function and is unable to consent, the patient's legal representative has agreed to the patient's participation in the study.
Key exclusion criteria (11 listed)
- Patients with implanted or externally applied electrical devices (such as pacemakers, defibrillators, implantable defibrillators, vagus nerve stimulators, spinal cord stimulators, gastric stimulators, diaphragm stimulators, etc.)
- Patients with a history of neck tumors, cervical spine instability, or neck surgery
- Patients with internal jugular vein catheters, infections, or inflammatory signs at the electrical stimulation site, making percutaneous phrenic nerve access impossible
- Patients with neurological or neuromuscular diseases that significantly affect respiratory muscle function
- Patients currently receiving neuromuscular blocking agents
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 |
|---|---|---|
| Transcutaneous, repetitive phrenic nerve electrical stimulationPhrenic nerve electrical stimulation with different stimulation intensity and frequency | Procedure or surgery | ICU patients |
Primary outcome
Maximum diaphragm thickness during phrenic nerve repetitive stimulation
Time frame: Measured one time between 48 hours after intubation and before extubation.
Maximum diaphragm thickness (mm)
Change in diaphragm thickness before and during phrenic nerve repetitive stimulation
Time frame: Measured one time between 48 hours after intubation and before extubation.
Change of diaphragm thickness (mm)
2 secondary outcomes
Amplitude of the phrenic nerve compound motor action potential during phrenic nerve repetitive stimulation
Time frame: Measured one time between 48 hours after intubation and before extubation.
Area of the phrenic nerve compound motor action potential during phrenic nerve repetitive stimulation
Time frame: Measured one time between 48 hours after intubation and before extubation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Sung Eun Hyun, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phrenic Nerve and Electrical Stimulation, run by Seoul National University Hospital at 1 site in South Korea.
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 11 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: finished, as of the sponsor's last update on 25 May 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum diaphragm thickness during phrenic nerve repetitive stimulation (time frame: Measured one time between 48 hours after intubation and before extubation.). The study lists 2 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 25 May 2025.