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

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 Overview

• Status: Completed
• Conditions: Electrical Stimulation; Phrenic Nerve
• Intervention / Treatment: Procedure: Transcutaneous, repetitive phrenic nerve electrical stimulation

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICU patients; ICU patient with mechanical ventilator	Procedure: Transcutaneous, repetitive phrenic nerve electrical stimulation; Phrenic nerve electrical stimulation with different stimulation intensity and frequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum diaphragm thickness during phrenic nerve repetitive stimulation	Maximum diaphragm thickness (mm)	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 one time between 48 hours after intubation and before extubation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amplitude of the phrenic nerve compound motor action potential during phrenic nerve repetitive stimulation	CMAP amplitude (mV)	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 one time between 48 hours after intubation and before extubation.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: National Research Foundation of Korea
• Investigators: Principal Investigator: Sung Eun Hyun, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: July 7, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2312-166-1498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No