Intensive Care Unit, Invasive Mechanical Ventilation
Conditions
Keywords
Intensive Care Unit, Invasive Mechanical Ventilation, Diaphragm weakness assessment, Rehabilitation
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.
Interventions
PROCEDUREMagnetic stimulation
Cervical bilateral phrenic nerve stimulation with the MagStim 200 tool.
PROCEDUREElectric 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)
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed