Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort (PATCH-MMG)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Device: non-invasive ventilation with or without resistance

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • Angers University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Actual): June 26, 2024
• Study Completion (Actual): June 26, 2024

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Acute respiratory failure; Respiratory effort; Surface mechanomyography
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 49RC22_0395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No