Different Positive Pressure Strategies in COPD Patients.

Universidade Federal de Pernambuco

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: Nonivasive ventilation; Device: Nebulization; Device: Positive expiratory pressure valve

Study type: Interventional

Funder types: Other

Identifiers

NCT03382197

UFPE_FISIO_RESP

Details and patient eligibility

About

Chronic obstructive pulmonary disease (COPD) is characterized by a poorly reversible airway obstruction and consequent systemic manifestations. Its high prevalence and high number of diagnosed patients has become a challenge for health services due to the costs of diagnosis and treatment of these patients. Positive pressure and aerosol therapy are preferred therapies for the management of COPD symptoms, but their effects when associated are poorly studied. The objective of this study is to compare the effects of different positive pressure strategies associated with aerosol therapy through Pulmonary Scintigraphy and Electrical Impedance Tomography (EIT) in patients with COPD in the intercrise period. This is a randomized, crossover, blinded and allocated crossover type clinical trial in which patients with moderate to severe COPD will be allocated to three intervention groups with different strategies for positive pressure associated with aerosol therapy: control group 1 nebulization), group 2 nebulization with EPAP valve and group 3 nebulization with NIV bi-level pressure mode. The radioaerosol deposition pattern will be evaluated through Pulmonary Scintigraphy and regional pulmonary ventilation through EIT.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with stage II (moderate) and III (severe) COPD according to the guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD)

Exclusion criteria

• unable to understand or perform procedures that present rheumatic or orthopedic diseases or deformities / abnormalities in the spine that compromise the mechanics of the respiratory system; respiratory comorbidities such as asthma, bronchiectasis and sequela of tuberculosis, cardiovascular and neurological comorbidities; hemodynamic instability defined as heart rate greater than 150 bpm, or systolic pressure less than 90 mmHg; hypertension (blood pressure> 149/89 mmHg) or hypotension (blood pressure <90/60 mmHg) at the time of collection; pregnancy or suspected pregnancy; and any contraindications for the use of PEP.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 3 patient groups

Nebulization

Experimental group

Description:

control intervention, will only perform nebulization;

Treatment:

Device: Nebulization

Positive expiratory pressure valve

Experimental group

Description:

Intervention, will perform nebulization associated with positive expiratory pressure valve in the airways (EPAP)

Treatment:

Device: Positive expiratory pressure valve

Nonivasive ventilation

Experimental group

Description:

intervention, will perform nebulization associated with non-invasive ventilation Bi-level mode;

Treatment:

Device: Nonivasive ventilation