Different Positive Pressure Strategies in COPD Patients.

Study Overview
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Brief Summary
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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.

Official Title
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Regional Ventilation and Radioaerosol Pulmonary Deposition Through Different Positive Pressure Strategies in COPD Patients.

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Nebulization
* Device: Positive expiratory pressure valve
* Device: Nonivasive ventilation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients will be randomized regarding the order of intervention they will receive: Group 1 - control intervention, will only perform nebulization; Group 2 - intervention, will perform nebulization associated with positive expiratory pressure valve in the airways (EPAP); Group 3 - intervention, will perform nebulization associated with non-invasive ventilation Bi-level mode; All patients will be evaluated BEFORE, DURING and AFTER each intervention through Electrical Impedance Tomography, Pulmonary Scintigraphy and Spirometry.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulization<br>control intervention, will only perform nebulization; | Device: Nebulization<br>* For inhalation of the radioaerosol a dose of DTPA-Tc99m (methionine-labeled diethylnitriaminepentaacetic acid) with 1mCi activity, associated with 10 drops of Fenoterol Bromide and 20 drops of Ipatropium Bromide diluted for a total of up to 3 ml of saline solution 0.9%. A MESH vibrating nebulizer (NIVO, Philips Respironics, Murrysville, Pennsylvania) will be used.<br>|
| Experimental: Positive expiratory pressure valve<br>Intervention, will perform nebulization associated with positive expiratory pressure valve in the airways (EPAP) | Device: Positive expiratory pressure valve<br>* For nebulization associated with the EPAP valve will be used a non-invasive distribution system consisting of a non-toxic orofacial mask connected to a spring loaded EPAP valve. This mask will be secured to the patient's face through tabs in order to prevent leakage and to maintain proper pressurizing and better patient adaptation.<br>|
| Experimental: Nonivasive ventilation<br>intervention, will perform nebulization associated with non-invasive ventilation Bi-level mode; | Device: Nonivasive ventilation<br>* For nebulization associated with NIV, a noninvasive distribution system consisting of a non-toxic orofacial mask connected to the NIV circuit will be used, and the latter will be being fed by a radioaerosol flow generated by a nebulizer coupled to the circuit. This mask will be secured to the patient's face through tabs in order to prevent leakage and to maintain proper pressurizing and better patient adaptation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pulmonary Function | Pulmonary function test performed through spirometry | 30 minutes after intervention | 
| Change of Aerosol deposition in the lungs | The pulmonary deposition index (PPI), expressed in percentage terms and obtained by the ratio of the number of counts of each ROI to the total number of counts of the respective lung. | Immediately after intervention | 
| Change of Regional pulmonary ventilation | The impedance variation (AZ) and regional pulmonary ventilation (ZEE) will be evaluated for each region of interest. | 30 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Ventilatory pattern | Respiratory rate, tidal volume, minute volume, inspiratory time, expiratory time, and total time. | 30 minutes after intervention | 
| Change of Heart Rate | Heart Rate | 30 minutes after intervention | 
| Change of Peripheral Oxygen Saturation | Peripheral Oxygen Saturation | Immediately and 30 minutes after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aerosol therapy, positive pressure, electrical impedance tomography, pulmonary scintigraphy