Trials / Completed
CompletedNCT04199273
Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- University Hospital, Montpellier · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2019-10-30
- Primary completion
- 2022-08-25
- Completion
- 2022-08-25
- First posted
- 2019-12-13
- Last updated
- 2022-09-16
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04199273. Inclusion in this directory is not an endorsement.