Expiratory Pressure in Healthy Individuals

Respiratory Physiology Clinical Trial

Official title:

Determining Factors of the Maximal Expiratory Pressure in Healthy Individuals: Influence of the Mouthpiece Configuration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06435793
• Other study ID #: P2024/081
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 18, 2024
• Est. completion date: September 18, 2025

Study information

• Verified date: May 2024
• Source: Laboratory of Movement, Condorcet, Tournai, Belgium
• Contact: Eliot Rudy Mbolo Ebubu (MD, PhD candidate)
• Phone: 0032485114738
• Email: 535678[@]umons.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 18, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Physiology

Intervention

Procedure:
• MEP measurement - Surface EMG - IOPI
Participants will undergo serial expiratory maneuvers using variously-sized circular mouthpieces and a reference ovoid-shaped mouthpiece. At each maneuver, the maximal expiratory mouth pressure at total lung capacity will be measured, alongside with the degree of neuromuscular activation of the internal oblique and transverse abdominal muscles using surface electromyography. The Orbicularis Oris strength will also be measured using the Iowa Oral Performance Instrument.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Laboratory of Movement, Condorcet, Tournai, Belgium	University of Mons

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal expiratory pressure		120 minutes
Primary	Root mean square of the EMG signal		120 minutes
Secondary	Orbicularis Oris Performance Index	Obtained after computational processing of participant photographs using a MatLab based software. This index is a newly developed marker of the Orbicularis Oris function based on different anthropometric variables	5 minutes
Secondary	Orbicularis Oris strength	Obtained through the Iowa Oral Performance Instrument	10 minutes