Ventilation Distribution in COPD Patients During Breathing Exercises

NCT06381973 | Completed

• 1 other identifier: ELTGOL
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Healthy

Outcome Measures

Primary Outcomes (1)

• Impedance variation using Electrical Impedance Tomography

  Impedance change in the right and left lungs

  2 minutes during intervention

Study Arms (5)

ELTGOL_Physio

ACTIVE COMPARATOR

ELTGOL + Manual pressure of the physiotherapist

Behavioral: ELTGOL_Physio

ELTGOL_Auto

ACTIVE COMPARATOR

ELTGOL performed autonomously

Behavioral: ELTGOL_Auto

PEP

ACTIVE COMPARATOR

Positive expiratory pressure (PEP)

Device: PEP

1L-Tidal-Breathing

ACTIVE COMPARATOR

Tidal-breathing of 1 liter per breath

Behavioral: 1L-Tidal-Breathing

Spontaneous Breathing

ACTIVE COMPARATOR

Behavioral: Spontaneous Breathing

Interventions

ELTGOL_Physio BEHAVIORAL

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_Physio

ELTGOL_Auto BEHAVIORAL

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.

ELTGOL_Auto

PEP DEVICE

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

PEP

1L-Tidal-Breathing BEHAVIORAL

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.

1L-Tidal-Breathing

Spontaneous Breathing BEHAVIORAL

The subject will be asked to breath spontaneously while being in the right lateral posture.

Spontaneous Breathing

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• William Poncin, PT, PhD: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 24, 2024
• Study Start: April 15, 2024
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

BE (1)