Ventilation Distribution in COPD Patients During Breathing Exercises

Not Applicable

Recruiting

• Conditions: Healthy; Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: ELTGOL_Physio; Behavioral: Spontaneous Breathing; Behavioral: ELTGOL_Auto; Device: PEP; Behavioral: 1L-Tidal-Breathing

• Registration Number: NCT06381973
• Lead Sponsor: William Poncin, PT, PhD

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.

Detailed 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.

Study Timeline

• Study Start: 2024-04-15
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ELTGOL_Physio	ELTGOL_Physio	ELTGOL + Manual pressure of the physiotherapist
Spontaneous Breathing	Spontaneous Breathing	-
ELTGOL_Auto	ELTGOL_Auto	ELTGOL performed autonomously
PEP	PEP	Positive expiratory pressure (PEP)
1L-Tidal-Breathing	1L-Tidal-Breathing	Tidal-breathing of 1 liter per breath

Primary Outcome Measures

Name	Time	Method
Impedance variation using Electrical Impedance Tomography	2 minutes during intervention	Impedance change in the right and left lungs

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Brussels Capital, Belgium