Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort

Study Overview
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Brief Summary
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Surface mechanomyography (sMMG) has been proposed as a tool to study muscle mechanical activity. sMMG is a noninvasive technique using specific transducers to record muscle surface oscillations due to mechanical activity of the motor units . It could be of major interest for the detection of respiratory efforts in patients with respiratory failure. This study aims at assessing the performances of sMMG to measure and detect respiratory drive and effort in healthy volunteers.

Official Title
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Performance of Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort in Healthy Volunteers - PATCH-MMG

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Device: non-invasive ventilation with or without resistance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy volunteer Age > 18 and < 60 Informed consent Fasting Subjects covered by or having the rights to medical care assurance Exclusion Criteria: Obesity (BMI > 30 kg.m-2) Respiratory disease Cardiovascular disease Contraindication to the insertion of a nasogastric tube Incapacity to consent Pregnancy, breastfeeding Bad understanding of the French language, Other protected person according to articles L1121.7 and L1121.8 of the French Public Health Act.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Esophageal pressure, electrical activity of the diaphram (Eadi) and sMMG will be recorded in 10 healthy subjects in spontaneous ventilation (SV) and non-invasive ventilation with or without resistance.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SV - R / SV + R / PSV<br>Spontaneous ventilation without resistance (SV - R) / Spontaneous ventilation with resistance (SV + R) / Pressure support ventilation (PSV) | Device: non-invasive ventilation with or without resistance<br>* non-invasive ventilation with or without resistance.<br>|
| Experimental: SV - R / PSV / SV + R<br>Spontaneous ventilation without resistance / Pressure support ventilation / Spontaneous ventilation with resistance | Device: non-invasive ventilation with or without resistance<br>* non-invasive ventilation with or without resistance.<br>|
| Experimental: SV + R / PSV / SV - R<br>Spontaneous ventilation with resistance / Pressure support ventilation / Spontaneous ventilation without resistance | Device: non-invasive ventilation with or without resistance<br>* non-invasive ventilation with or without resistance.<br>|
| Experimental: SV + R / SV - R / PSV<br>Spontaneous ventilation with resistance / Spontaneous ventilation without resistance / Pressure support ventilation | Device: non-invasive ventilation with or without resistance<br>* non-invasive ventilation with or without resistance.<br>|
| Experimental: PSV / SV + R / SV - R<br>Pressure support ventilation / Spontaneous ventilation with resistance / Spontaneous ventilation without resistance | Device: non-invasive ventilation with or without resistance<br>* non-invasive ventilation with or without resistance.<br>|
| Experimental: PSV / SV - R / SV + R<br>Pressure support ventilation / Spontaneous ventilation without resistance / Spontaneous ventilation with resistance | Device: non-invasive ventilation with or without resistance<br>* non-invasive ventilation with or without resistance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of sMMG to detect respiratory effort | Delays between the beginning of the respiratory effort detected by sMMG and Eadi and the end of the respiratory effort detected by sMMG and Eadi (msec) | 5 minutes after the beginning of recording | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between sMMG-time (MMG-TP) and PTPes-Pes Peak | Accuracy of sMMG to assess the intensity of respiratory effort (in comparison with pressure-time product in cm H2O.s.min-1) | 5 minutes after the beginning of recording | 
| Comparison between sMMG slope & Eadi parameters | Accuracy of sMMG to assess the intensity of respiratory drive (in comparison with Eadi in microvolt) | 5 minutes after the beginning of recording | 
| Comparison between sMMG slope & slope Peso | Accuracy of sMMG to assess the intensity of respiratory drive (in comparison Peso in cm H20) | 5 minutes after the beginning of recording | 
| Delay between neural time measured by sMMG and neural time measured by Eadi | Accuracy of sMMG to assess the duration of inspiratory neural time (in comparison with Eadi in msec) | 5 minutes after the beginning of recording | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute respiratory failure, Surface mechanomyography, Respiratory effort