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Repetitive Phrenic Nerve Stimulation in Critically Ill Patients Under Mechanical Ventilation

Non-Invasive Transcutaneous Repetitive Phrenic Nerve Stimulation Assessment in Critically Ill Patients Under Mechanical Ventilation - Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06491511
Enrollment
5
Registered
2024-07-09
Start date
2024-06-17
Completion date
2024-09-20
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrical Stimulation, Phrenic Nerve

Brief 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. 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.

Interventions

Phrenic nerve electrical stimulation with different stimulation intensity and frequency

Sponsors

National Research Foundation of Korea
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Maximum diaphragm thickness during phrenic nerve repetitive stimulationMeasured one time between 48 hours after intubation and before extubation.Maximum diaphragm thickness (mm)
Change in diaphragm thickness before and during phrenic nerve repetitive stimulationMeasured one time between 48 hours after intubation and before extubation.Change of diaphragm thickness (mm)

Secondary

MeasureTime frameDescription
Amplitude of the phrenic nerve compound motor action potential during phrenic nerve repetitive stimulationMeasured one time between 48 hours after intubation and before extubation.CMAP amplitude (mV)
Area of the phrenic nerve compound motor action potential during phrenic nerve repetitive stimulationMeasured one time between 48 hours after intubation and before extubation.CMAP area (ms\*mV)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026