Ventilation Distribution in COPD Patients During Breathing Exercises

Healthy Clinical Trial

Official title:

Influence of Airway Clearance Techniques on Ventilation Distribution in the Lateral Posture in COPD and Healthy Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381973
• Other study ID #: ELTGOL
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: April 2024
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: William Poncin
• Phone: +3227642316
• Email: william.poncin[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ELTGOL (Slow Expiration with the Opened Glottis in the Lateral posture) is an airway clearance technique performed in the lateral decubitus position. This technique focuses on optimizing ventilation of the infralateral lung (when the subject is lying in the lateral posture) to enhance local air-liquid interaction. Previous studies on ventilation differences between the infra- and supralateral lungs were conducted on healthy, young, male subjects, without the application of thoracic or abdominal pressure. This study aimed to assess ventilation distribution in right lateral recumbency in patients with chronic obstructive pulmonary disease (COPD), as well as healthy individuals, and investigate the impact of thoracic and abdominal manual pressures during ELTGOL on ventilation distribution.

Description:

Electrical impedance tomography will be used to verify the effect of the lateral posture and associated breathing techniques in COPD and healthy individuals. The subjects will be placed in a standardised position before the measurements begin. The subjects will be placed in a right lateral recumbency position. The protocol comprises four manoeuvres, each interrupted by a short rest phase. Each subject will begin the experiment with the spontaneous ventilation manoeuvre in order to obtain the reference ventilation distribution. This will be followed by four other manoeuvres during which ventilation was measured: 1) using an spirometer to obtain a tidal volume of 1L, 2) performing the ELTGOL technique independently, 3) performing the ELTGOL technique assisted by manual pressures applied by a physiotherapist. 4) using a positive expiratory pressure (PEP) device.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Healthy subjects: No acute or chronic respiratory disease, normal lung function, non-smoker.
• Patients with COPD: forced expiratory volume at one second (FEV1) = 80% predicted value, in stable state.

Exclusion Criteria:

• Healthy subjects: obesity (BMI > 35kg/m²); active or former smoker; severe scoliosis; cardiovascular or neuromuscular disease; active implant (cardiac pacemaker or an implantable cardioverter-defibrillator (ICD); thoracic skin lesion.
• Patients with COPD: obesity (BMI > 35kg/m²); severe scoliosis; severe cardiovascular disease; neuromuscular disease; active implant (cardiac pacemaker or an implantable cardioverter-defibrillator (ICD); thoracic skin lesion.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Healthy
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• ELTGOL_Physio
The subject will be asked to slowly exhale with the glottis opened in the right lateral posture. The physiotherapist will accompany the subject by gently applying manual pressure on the chest wall and the abdomen during expiratory phases.
• ELTGOL_Auto
The subject will be asked to slowly exhale with the glottis opened in the right lateral posture. The physiotherapist will not intervene in this arm.

Device:
• PEP
The subject will be asked to exhale through a positive expiratory pressure (PEP) device (Threshold PEP) while being in the right lateral posture.

Behavioral:
• 1L-Tidal-Breathing
The subject will be asked to breath with a fixed tidal-breathing of 1 liter per breath (monitored via a spirometer) while being in the right lateral posture.
• Spontaneous Breathing
The subject will be asked to breath spontaneously while being in the right lateral posture.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels	Brussels Capital

Sponsors (1)

Lead Sponsor	Collaborator
William Poncin, PT, PhD

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impedance variation using Electrical Impedance Tomography	Impedance change in the right and left lungs	2 minutes during intervention