Ventilation Distribution in COPD Patients During Breathing Exercises

William Poncin, PT, PhD

Status: Enrolling

Conditions: Healthy; Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: ELTGOL_Physio; Device: PEP; Behavioral: Spontaneous Breathing; Behavioral: ELTGOL_Auto; Behavioral: 1L-Tidal-Breathing

Study type: Interventional

Funder types: Other

Identifiers

NCT06381973

ELTGOL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 5 patient groups

ELTGOL_Physio

Active Comparator group

Description:

ELTGOL + Manual pressure of the physiotherapist

Treatment:

Behavioral: ELTGOL_Physio

ELTGOL_Auto

Active Comparator group

Description:

ELTGOL performed autonomously

Treatment:

Behavioral: ELTGOL_Auto

PEP

Active Comparator group

Description:

Positive expiratory pressure (PEP)

Treatment:

Device: PEP

1L-Tidal-Breathing

Active Comparator group

Description:

Tidal-breathing of 1 liter per breath

Treatment:

Behavioral: 1L-Tidal-Breathing

Spontaneous Breathing

Active Comparator group

Treatment:

Behavioral: Spontaneous Breathing