SONOSTIM: Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 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) |
Procedure: Magnetic stimulation
Cervical bilateral phrenic nerve stimulation with the MagStim 200 tool.
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)
|
Experimental: 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 |
Procedure: Magnetic stimulation
Cervical bilateral phrenic nerve stimulation with the MagStim 200 tool.
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)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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).
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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ICU patient with invasive mechanical ventilation
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Sedated patient with a Richmond Agitation-Sedation Scale of -4 or -5
Exclusion Criteria:
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Contraindication for magnetic stimulation (Pacemaker)
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Hemodynamic or respiratory instability : PaO2/FiO2 < 200 mmHg, noradrenaline > 0,3 µg/kg/min, dobutamine > 10 µg/kg/min
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Neuromuscular disease or recent use of neuromuscular blocking agents (2h30) with a TOF ratio below 4/4 95%.
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Refusal of study participation or to pursue the study by the patient, no consent
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Pregnancy or breastfeeding
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Absence of coverage by the French statutory healthcare insurance system
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Centre Hospitalier Universitaire Saint Eloi | Montpellier | Herault | France | 34000 |
Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
- Study Director: Samir Jaber, MD, PHD, Montpellier University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RECHMPL19_0202