Ventilation Distribution in COPD Patients During Breathing Exercises

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2025-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ELTGOL_Physio

ELTGOL + Manual pressure of the physiotherapist

Group Type ACTIVE_COMPARATOR

ELTGOL_Physio

Intervention Type 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_Auto

ELTGOL performed autonomously

Group Type ACTIVE_COMPARATOR

ELTGOL_Auto

Intervention Type 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.

PEP

Positive expiratory pressure (PEP)

Group Type ACTIVE_COMPARATOR

PEP

Intervention Type DEVICE

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

1L-Tidal-Breathing

Tidal-breathing of 1 liter per breath

Group Type ACTIVE_COMPARATOR

1L-Tidal-Breathing

Intervention Type 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.

Spontaneous Breathing

Group Type ACTIVE_COMPARATOR

Spontaneous Breathing

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

PEP

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

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Spontaneous Breathing

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes