Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking

NCT04199273 | Completed

• 1 other identifier: RECHMPL19_0202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Development and validation of a new affordable and easy-to-use phrenic nerve stimulation tool for diaphragm strength assessment in intensive care unit

Conditions

Intensive Care Unit; Invasive Mechanical Ventilation

Keywords

Intensive Care Unit; Invasive Mechanical Ventilation; Diaphragm weakness assessment; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Tracheal pressure (Ptrach) during diaphragm pacing

  Negative pressure in the occluded breathing circuit, assessed with a manometer located just after the endotracheal tube, during diaphragm stimulation

  During electric of magnetic phrenic nerve stimulation

Secondary Outcomes (2)

• Behavioral Pain Scale (BPS) after stimulation

  Immediately after phrenic nerve stimulation

• Distance in millimeter between anatomical and ultrasound phrenic nerve location

  During ultrasonography phrenic nerve tracking

Study Arms (2)

Magnetic stimulation and electric stimulation

EXPERIMENTAL

The patient receive first the magnetic stimulation with MagStim 200 tool. Then 15 min after he will receive the electric stimulation with the SonoStim tool : ultrasonography phrenic nerve tracking and targeted electric stimulation with a nerve stimulator usually used for neuromuscular transmission monitoring (TOFScan, Drager)

Procedure: Magnetic stimulation; Procedure: Electric stimulation

Electric stimulation and magnetic stimulation

EXPERIMENTAL

The patient receive first electric stimulation with the SonoStim tool : ultrasonography phrenic nerve tracking and targeted electric stimulation with a nerve stimulator usually used for neuromuscular transmission monitoring (TOFScan, Drager). Then 15 min after he will receive the magnetic stimulation with MagStim 200 tool

Procedure: Magnetic stimulation; Procedure: Electric stimulation

Interventions

Magnetic stimulation PROCEDURE

Cervical bilateral phrenic nerve stimulation with the MagStim 200 tool.

Electric stimulation and magnetic stimulation; Magnetic stimulation and electric stimulation

Electric stimulation PROCEDURE

Cervical bilateral phrenic nerve stimulation after ultrasonography nerve tracking and targeted electric stimulation with a nerve stimulator usually used for neuromuscular transmission monitoring (TOFScan, Drager)

Electric stimulation and magnetic stimulation; Magnetic stimulation and electric stimulation

Eligibility Criteria

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

You may qualify if:

• ICU patient with invasive mechanical ventilation
• Sedated patient with a Richmond Agitation-Sedation Scale of -4 or -5

You may not qualify if:

• Contraindication for magnetic stimulation (Pacemaker)
• Hemodynamic or respiratory instability : PaO2/FiO2 \< 200 mmHg, noradrenaline \> 0,3 µg/kg/min, dobutamine \> 10 µg/kg/min
• Neuromuscular disease or recent use of neuromuscular blocking agents (2h30) with a TOF ratio below 4/4 95%.
• Refusal of study participation or to pursue the study by the patient, no consent
• Pregnancy or breastfeeding
• Absence of coverage by the French statutory healthcare insurance system

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Centre Hospitalier Universitaire Saint Eloi

Montpellier, Herault, 34000, France

Location

Related Publications (1)

• Capdevila M, De Jong A, Belafia F, Vonarb A, Carr J, Molinari N, Choquet O, Capdevila X, Jaber S. Ultrasound-guided Transcutaneous Phrenic Nerve Stimulation in Critically Ill Patients: A New Method to Evaluate Diaphragmatic Function. Anesthesiology. 2025 Mar 1;142(3):522-531. doi: 10.1097/ALN.0000000000005267. Epub 2024 Oct 21.

  PMID: 39432817 DERIVED

MeSH Terms

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Samir Jaber, MD, PHD

  Montpellier University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient, serving as their own control, receives both types of phrenic nerve stimulation : magnetic stimulation and electric stimulation. The order is randomized. For avoid a carry-over effect (diaphragm potentiation), a wash-out period of 15 minutes will be respected between the two type of stimulation.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 13, 2019
• Study Start: October 30, 2019
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months after the main publication
• Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.

Locations

FR (1)