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

Not Applicable

Completed

• Conditions: Intensive Care Unit; Invasive Mechanical Ventilation
• Interventions: Procedure: Magnetic stimulation; Procedure: Electric stimulation

• Registration Number: NCT04199273
• Lead Sponsor: University Hospital, Montpellier

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

Detailed 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.

Study Timeline

• Study Start: 2019-10-30
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Primary Completion: 2022-08-25
• Study Completion: 2022-08-25
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Magnetic stimulation and electric stimulation	Magnetic 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)
Electric stimulation and magnetic stimulation	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
Magnetic stimulation and electric stimulation	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)
Electric stimulation and magnetic stimulation	Electric 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

Primary Outcome Measures

Name	Time	Method
Tracheal pressure (Ptrach) during diaphragm pacing	During electric of magnetic phrenic nerve stimulation	Negative pressure in the occluded breathing circuit, assessed with a manometer located just after the endotracheal tube, during diaphragm stimulation

Secondary Outcome Measures

Name	Time	Method
Distance in millimeter between anatomical and ultrasound phrenic nerve location	During ultrasonography phrenic nerve tracking	Distance between classical anatomical landmarks of the phrenic nerve location (underneath the posterior border of the sternocleidomastoid muscle, at the level of the cricoid cartilage), and the phrenic nerve location with ultrasound
Behavioral Pain Scale (BPS) after stimulation	Immediately after phrenic nerve stimulation	The BPS is a scale of pain for critical care patients, from 3 (no or minimal pain) to 12 points (maximum pain).

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Saint Eloi; 🇫🇷 Montpellier, Herault, France