Clinical trial NCT06435793: Expiratory Pressure in Healthy Individuals
Official title: Determining Factors of the Maximal Expiratory Pressure in Healthy Individuals: Influence of the Mouthpiece Configuration
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Physiology
Lead sponsor: Laboratory of Movement, Condorcet, Tournai, Belgium
Sponsor class: OTHER
Collaborators: name: University of Mons
First posted: 2024-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The present study aims at enhancing our understanding of the influence of the mouthpiece configuration on the amplitude of oral pressures generated during a maximum expiratory pressure maneuver and on the neuromuscular recruitment of expiratory muscles (more specifically of the internal oblique and the transverse abdominal muscles).

Incidentally, it also aims at clarifying the role of orofacial muscles, if any, in the neuromuscular recruitment of the aforementioned muscles.

Detailed description: Enhancing our understanding of the influence of the mouthpiece configuration on oral pressures and on the neuromuscular recruitment of the internal oblique and the transverse abdominal muscles during a maximum expiratory pressure (MEP) maneuver is the primary goal of this study

Maximal Respiratory Mouth Pressures (MIP and MEP):

Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are commonly used indices to assess respiratory muscle strength at the mouth.

MIP measures the strength of inspiratory muscles, while MEP assesses expiratory muscle strength.

These measurements are simple, convenient, and noninvasive. However, clear standards for these measurements are not well-established.

Choice of Mouthpiece:

We propose exploring different mouthpiece designs to know their impact on pressure measurements.

Influence of Mouthpiece Design:

The type of mouthpiece used can affect pressure measurements. Some investigators recommend including a small leak in the measuring circuit to dissipate pressure generated in the mouth and minimize measurement errors.

However, specific studies focusing on the influence of mouthpiece design on MEP and neuromuscular recruitment of expiratory muscles (such as the internal oblique and transverse muscles) during MEP maneuvers would be valuable.

Additional Considerations:

Factors like body position (sitting vs. half-lying) may also impact pressure measurements, although no significant differences were found in one study.

Among the objectives of our study, we aim at exploring ways to improve the accuracy and reliability of respiratory pressure measurements.

In summary, understanding the impact of mouthpiece design on oral pressures during MEP maneuvers is essential for accurate assessment of respiratory muscle function. Further research in this area could provide valuable insights for clinical practice and pulmonary function laboratories.

Eligibility criteria: Inclusion Criteria:

* Age over 18

Exclusion Criteria:

* Any neuromuscular disease or condition susceptible to interfere with the results
* Pregnant women
* Any contraindications to the realization of maximal expiratory maneuvers, as defined in the ATS Pulmonary Function Laboratory Management And Procedure Manual (3rd Edition)
* Excessive abdominal gird, compromising ultrasonographic positioning of electrodes or altering signal quality

Primary outcomes:
measure: Maximal expiratory pressure
timeFrame: 120 minutes
measure: Root mean square of the EMG signal
timeFrame: 120 minutes
Secondary outcomes:
measure: Orbicularis Oris Performance Index
timeFrame: 5 minutes
measure: Orbicularis Oris strength
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Mons
name: Alexandre Legrand (MD, PhD)
role: PRINCIPAL_INVESTIGATOR
affiliation: Provincial High School of Hainaut, Condorcet
name: Frederic Duprez (PhD)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mons
name: Eliot Rudy Mbolo Ebubu (MD, PhD candidate)
role: PRINCIPAL_INVESTIGATOR
References: