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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2022-08-25

Brief Summary

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

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Detailed Description

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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.

Conditions

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Intensive Care Unit Invasive Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Magnetic stimulation and electric stimulation

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)

Group Type EXPERIMENTAL

Magnetic stimulation

Intervention Type PROCEDURE

Cervical bilateral phrenic nerve stimulation with the MagStim 200 tool.

Electric stimulation

Intervention Type 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

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

Group Type EXPERIMENTAL

Magnetic stimulation

Intervention Type PROCEDURE

Cervical bilateral phrenic nerve stimulation with the MagStim 200 tool.

Electric stimulation

Intervention Type 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)

Interventions

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Magnetic stimulation

Cervical bilateral phrenic nerve stimulation with the MagStim 200 tool.

Intervention Type PROCEDURE

Electric stimulation

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)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No