Clinical trial NCT04199273: Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking
Official title: Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking : a Randomized, Cross Over, Physiologic Study in Critically Ill Patients Requiring Invasive Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit
Invasive Mechanical Ventilation
Keywords: Intensive Care Unit
Invasive Mechanical Ventilation
Diaphragm weakness assessment
Rehabilitation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tracheal pressure (Ptrach) during diaphragm pacing
timeFrame: During electric of magnetic phrenic nerve stimulation
Secondary outcomes:
measure: Behavioral Pain Scale (BPS) after stimulation
timeFrame: Immediately after phrenic nerve stimulation
measure: Distance in millimeter between anatomical and ultrasound phrenic nerve location
timeFrame: During ultrasonography phrenic nerve tracking
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire Saint Eloi
state: Herault
Study officials:
affiliation: Montpellier University Hospital
name: Samir Jaber, MD, PHD
role: STUDY_DIRECTOR
References: