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

Primary Purpose

Acute Respiratory Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
non-invasive ventilation with or without resistance
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Acute Respiratory Failure focused on measuring Acute respiratory failure, Surface mechanomyography, Respiratory effort

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Angers University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

SV - R / SV + R / PSV

SV - R / PSV / SV + R

SV + R / PSV / SV - R

SV + R / SV - R / PSV

PSV / SV + R / SV - R

PSV / SV - R / SV + R

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Comparison between sMMG slope & Eadi parameters
Accuracy of sMMG to assess the intensity of respiratory drive (in comparison with Eadi in microvolt)
Comparison between sMMG slope & slope Peso
Accuracy of sMMG to assess the intensity of respiratory drive (in comparison Peso in cm H20)
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)

Full Information

First Posted
August 31, 2023
Last Updated
September 18, 2023
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT06046898
Brief Title
Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
Acute respiratory failure, Surface mechanomyography, Respiratory effort

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Outcomes Assessor
Masking Description
Recordings will be analysed by investigators blind to ventilation conditions
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SV - R / SV + R / PSV
Arm Type
Experimental
Arm Description
Spontaneous ventilation without resistance (SV - R) / Spontaneous ventilation with resistance (SV + R) / Pressure support ventilation (PSV)
Arm Title
SV - R / PSV / SV + R
Arm Type
Experimental
Arm Description
Spontaneous ventilation without resistance / Pressure support ventilation / Spontaneous ventilation with resistance
Arm Title
SV + R / PSV / SV - R
Arm Type
Experimental
Arm Description
Spontaneous ventilation with resistance / Pressure support ventilation / Spontaneous ventilation without resistance
Arm Title
SV + R / SV - R / PSV
Arm Type
Experimental
Arm Description
Spontaneous ventilation with resistance / Spontaneous ventilation without resistance / Pressure support ventilation
Arm Title
PSV / SV + R / SV - R
Arm Type
Experimental
Arm Description
Pressure support ventilation / Spontaneous ventilation with resistance / Spontaneous ventilation without resistance
Arm Title
PSV / SV - R / SV + R
Arm Type
Experimental
Arm Description
Pressure support ventilation / Spontaneous ventilation without resistance / Spontaneous ventilation with resistance
Intervention Type
Device
Intervention Name(s)
non-invasive ventilation with or without resistance
Intervention Description
non-invasive ventilation with or without resistance.
Primary Outcome Measure Information:
Title
Accuracy of sMMG to detect respiratory effort
Description
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)
Time Frame
5 minutes after the beginning of recording
Secondary Outcome Measure Information:
Title
Comparison between sMMG-time (MMG-TP) and PTPes-Pes Peak
Description
Accuracy of sMMG to assess the intensity of respiratory effort (in comparison with pressure-time product in cm H2O.s.min-1)
Time Frame
5 minutes after the beginning of recording
Title
Comparison between sMMG slope & Eadi parameters
Description
Accuracy of sMMG to assess the intensity of respiratory drive (in comparison with Eadi in microvolt)
Time Frame
5 minutes after the beginning of recording
Title
Comparison between sMMG slope & slope Peso
Description
Accuracy of sMMG to assess the intensity of respiratory drive (in comparison Peso in cm H20)
Time Frame
5 minutes after the beginning of recording
Title
Delay between neural time measured by sMMG and neural time measured by Eadi
Description
Accuracy of sMMG to assess the duration of inspiratory neural time (in comparison with Eadi in msec)
Time Frame
5 minutes after the beginning of recording

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François BELONCLE, Doctor
Phone
+33241353815
Email
francois.beloncle@chu-angers.fr
Facility Information:
Facility Name
Angers University Hospital
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Beloncle, MD PhD
Phone
+33 2 41 35 38 15
Email
francois.beloncle@chu-angers.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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