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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04199273
Collaborator
(none)
120
1
2
40.1
3

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
  • Procedure: Magnetic stimulation
  • Procedure: Electric stimulation
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

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Oct 30, 2019
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Mar 3, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

  2. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04199273
Other Study ID Numbers:
  • RECHMPL19_0202
First Posted:
Dec 13, 2019
Last Update Posted:
Dec 30, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier

Study Results

No Results Posted as of Dec 30, 2021