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

• Sponsor: University Hospital, Angers (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06046898
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure	Device: non-invasive ventilation with or without resistance	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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.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 (Outcomes Assessor)
• Masking Description: Recordings will be analysed by investigators blind to ventilation conditions
• Primary Purpose: Device Feasibility
• Official Title: Performance of Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort in Healthy Volunteers - PATCH-MMG
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Accuracy of sMMG to detect respiratory effort [5 minutes after the beginning of recording]

   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)

Secondary Outcome Measures

1. Comparison between sMMG-time (MMG-TP) and PTPes-Pes Peak [5 minutes after the beginning of recording]

   Accuracy of sMMG to assess the intensity of respiratory effort (in comparison with pressure-time product in cm H2O.s.min-1)

2. Comparison between sMMG slope & Eadi parameters [5 minutes after the beginning of recording]

   Accuracy of sMMG to assess the intensity of respiratory drive (in comparison with Eadi in microvolt)

3. Comparison between sMMG slope & slope Peso [5 minutes after the beginning of recording]

   Accuracy of sMMG to assess the intensity of respiratory drive (in comparison Peso in cm H20)

4. Delay between neural time measured by sMMG and neural time measured by Eadi [5 minutes after the beginning of recording]

   Accuracy of sMMG to assess the duration of inspiratory neural time (in comparison with Eadi in msec)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Angers University Hospital	Angers		France	49000

Sponsors and Collaborators

• University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT06046898
• Other Study ID Numbers: 49RC22_0395
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Angers: Acute respiratory failure; Surface mechanomyography; Respiratory effort
• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

No Results Posted as of Sep 21, 2023