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

Acute Respiratory Failure Clinical Trial

— PATCH-MMG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06046898
• Other study ID #: 49RC22_0395
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Angers
• Contact: François BELONCLE, Doctor
• Phone: +33241353815
• Email: francois.beloncle[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• non-invasive ventilation with or without resistance
non-invasive ventilation with or without resistance.

Locations

Country	Name	City	State
France	Angers University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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