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

NCT ID: NCT06046898

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2024-06-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

CROSSOVER

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.
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Outcome Assessors
Recordings will be analysed by investigators blind to ventilation conditions

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SV - R / SV + R / PSV

Spontaneous ventilation without resistance (SV - R) / Spontaneous ventilation with resistance (SV + R) / Pressure support ventilation (PSV)

Group Type EXPERIMENTAL

non-invasive ventilation with or without resistance

Intervention Type DEVICE

non-invasive ventilation with or without resistance.

SV - R / PSV / SV + R

Spontaneous ventilation without resistance / Pressure support ventilation / Spontaneous ventilation with resistance

Group Type EXPERIMENTAL

non-invasive ventilation with or without resistance

Intervention Type DEVICE

non-invasive ventilation with or without resistance.

SV + R / PSV / SV - R

Spontaneous ventilation with resistance / Pressure support ventilation / Spontaneous ventilation without resistance

Group Type EXPERIMENTAL

non-invasive ventilation with or without resistance

Intervention Type DEVICE

non-invasive ventilation with or without resistance.

SV + R / SV - R / PSV

Spontaneous ventilation with resistance / Spontaneous ventilation without resistance / Pressure support ventilation

Group Type EXPERIMENTAL

non-invasive ventilation with or without resistance

Intervention Type DEVICE

non-invasive ventilation with or without resistance.

PSV / SV + R / SV - R

Pressure support ventilation / Spontaneous ventilation with resistance / Spontaneous ventilation without resistance

Group Type EXPERIMENTAL

non-invasive ventilation with or without resistance

Intervention Type DEVICE

non-invasive ventilation with or without resistance.

PSV / SV - R / SV + R

Pressure support ventilation / Spontaneous ventilation without resistance / Spontaneous ventilation with resistance

Group Type EXPERIMENTAL

non-invasive ventilation with or without resistance

Intervention Type DEVICE

non-invasive ventilation with or without resistance.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

non-invasive ventilation with or without resistance

non-invasive ventilation with or without resistance.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Angers University Hospital

Angers, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

49RC22_0395

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.