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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06046898
Other study ID # 49RC22_0395
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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