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Completed

NCT Number: NCT04199273

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Saint Eloi

Montpellier, Herault, 34000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

magnetic stimulation

Procedure

Cervical bilateral phrenic nerve stimulation with the MagStim 200 tool.

Electric stimulation

Procedure

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)

Primary outcomes

  1. Tracheal pressure (Ptrach) during diaphragm pacing

    Time frame: 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 outcomes

  1. Behavioral Pain Scale (BPS) after stimulation

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Acronym: SONOSTIM

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2019
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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