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

Intensive Care Unit Clinical Trial

— SONOSTIM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04199273
• Other study ID #: RECHMPL19_0202
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: August 25, 2022

Study information

• Verified date: September 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 25, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit
• Invasive Mechanical Ventilation

Intervention

Procedure:
• Magnetic stimulation
Cervical bilateral phrenic nerve stimulation with the MagStim 200 tool.
• 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)

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Saint Eloi	Montpellier	Herault

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During electric of magnetic phrenic nerve stimulation
Secondary	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).	Immediately after phrenic nerve stimulation
Secondary	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	During ultrasonography phrenic nerve tracking