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

University Hospital Center (CHU)

Status: Completed

Conditions: Invasive Mechanical Ventilation; Intensive Care Unit

Treatments: Procedure: Electric stimulation; Procedure: Magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04199273

RECHMPL19_0202

Details and patient eligibility

About

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

Full description

In intensive care unit, various forms of sepsis, undernutrition, surgery, global inflammation, iatrogeny, and mechanical ventilation, contribute to the overall muscular involvement including the diaphragm.

Assessment of diaphragm dysfunction is a critical issue for patients under mechanical ventilation, providing prognosis information and leading to the best therapeutic choices.

Up to now, for sedated ventilated critical care patient, expensive magnetic phrenic nerve stimulation equipment is needed to evaluate diaphragm strength.

In this study, the investigators aim to develop an affordable easy-to-use phrenic nerve stimulation tool, with ultrasonography and a nerve stimulator usually used for neuromuscular transmission monitoring. Hypothesis is that phrenic pacing using this new method is equivalent to the Gold Standard.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Magnetic stimulation and electric stimulation

Experimental group

Description:

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)

Treatment:

Procedure: Magnetic stimulation

Procedure: Electric stimulation

Electric stimulation and magnetic stimulation

Experimental group

Description:

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

Treatment:

Procedure: Magnetic stimulation

Procedure: Electric stimulation