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

N/ACompletedNCT04199273

University Hospital, Montpellier120 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

120

Conditions

Intensive Care Unit Invasive Mechanical Ventilation

Interventions

Magnetic stimulationPROCEDURE

Cervical bilateral phrenic nerve stimulation with the MagStim 200 tool.

Electric stimulationPROCEDURE

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Universitaire Saint Eloi

Montpellier, Herault, France

Outcomes

Primary Outcomes

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

Time frame: During electric of magnetic phrenic nerve stimulation

Secondary Outcomes

Behavioral Pain Scale (BPS) after stimulation

The BPS is a scale of pain for critical care patients, from 3 (no or minimal pain) to 12 points (maximum pain).

Time frame: Immediately after phrenic nerve stimulation

Distance in millimeter between anatomical and ultrasound phrenic nerve location

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

Time frame: During ultrasonography phrenic nerve tracking

Data from ClinicalTrials.gov

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