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

NCT06046898 | Completed

• 1 other identifier: 49RC22_0395
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Keywords

Acute respiratory failure; Surface mechanomyography; Respiratory effort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Comparison between sMMG-time (MMG-TP) and PTPes-Pes Peak

  5 minutes after the beginning of recording

• Comparison between sMMG slope & Eadi parameters

  5 minutes after the beginning of recording

• Comparison between sMMG slope & slope Peso

  5 minutes after the beginning of recording

• Delay between neural time measured by sMMG and neural time measured by Eadi

  5 minutes after the beginning of recording

Study Arms (6)

SV - R / SV + R / PSV

EXPERIMENTAL

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

Device: non-invasive ventilation with or without resistance

SV - R / PSV / SV + R

EXPERIMENTAL

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

Device: non-invasive ventilation with or without resistance

SV + R / PSV / SV - R

EXPERIMENTAL

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

Device: non-invasive ventilation with or without resistance

SV + R / SV - R / PSV

EXPERIMENTAL

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

Device: non-invasive ventilation with or without resistance

PSV / SV + R / SV - R

EXPERIMENTAL

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

Device: non-invasive ventilation with or without resistance

PSV / SV - R / SV + R

EXPERIMENTAL

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

Device: non-invasive ventilation with or without resistance

Interventions

non-invasive ventilation with or without resistance DEVICE

non-invasive ventilation with or without resistance.

PSV / SV + R / SV - R; PSV / SV - R / SV + R; SV + R / PSV / SV - R; SV + R / SV - R / PSV; SV - R / PSV / SV + R; SV - R / SV + R / PSV

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteer
• Age \> 18 and \< 60
• Informed consent
• Fasting
• Subjects covered by or having the rights to medical care assurance

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers University Hospital

Angers, 49000, France

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Recordings will be analysed by investigators blind to ventilation conditions
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 21, 2023
• Study Start: November 6, 2023
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

FR (1)