Repetitive Phrenic Nerve Stimulation in Critically Ill Patients Under Mechanical Ventilation

NCT06491511 | Completed

• 1 other identifier: 2312-166-1498
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Phrenic Nerve; Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Amplitude of the phrenic nerve compound motor action potential during phrenic nerve repetitive stimulation

  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

  Measured one time between 48 hours after intubation and before extubation.

Study Arms (1)

ICU patients

ICU patient with mechanical ventilator

Procedure: Transcutaneous, repetitive phrenic nerve electrical stimulation

Interventions

Transcutaneous, repetitive phrenic nerve electrical stimulation PROCEDURE

Phrenic nerve electrical stimulation with different stimulation intensity and frequency

ICU patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

Study Officials

• Sung Eun Hyun, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor (MD, PhD)

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 9, 2024
• Study Start: June 17, 2024
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

KR (1)