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

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

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

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit; Invasive Mechanical Ventilation
• Intervention / Treatment: Procedure: Magnetic stimulation; Procedure: Electric stimulation

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Herault
    • Montpellier, Herault, France, 34000
      • Centre Hospitalier Universitaire Saint Eloi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Samir Jaber, MD, PHD, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): August 25, 2022
• Study Completion (Actual): August 25, 2022

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Intensive Care Unit; Invasive Mechanical Ventilation; Diaphragm weakness assessment
• Other Study ID Numbers: RECHMPL19_0202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual patient data will be made available upon a reasonable request
• IPD Sharing Time Frame: 12 months after the main publication
• IPD Sharing Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No