Skip to main content
OpenTrials
Completed

NCT Number: NCT06491511

Repetitive Phrenic Nerve Stimulation in Critically Ill Patients Under Mechanical Ventilation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous, repetitive phrenic nerve electrical stimulation

Procedure

Phrenic nerve electrical stimulation with different stimulation intensity and frequency

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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.

    CMAP amplitude (mV)

  2. 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.

    CMAP area (ms*mV)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2024
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.