Clinical trial NCT03382197: Different Positive Pressure Strategies in COPD Patients.
Official title: Regional Ventilation and Radioaerosol Pulmonary Deposition Through Different Positive Pressure Strategies in COPD Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: aerosol therapy
positive pressure
electrical impedance tomography
pulmonary scintigraphy
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of Pulmonary Function
timeFrame: 30 minutes after intervention
measure: Change of Aerosol deposition in the lungs
timeFrame: Immediately after intervention
measure: Change of Regional pulmonary ventilation
timeFrame: 30 minutes after intervention
Secondary outcomes:
measure: Change of Ventilatory pattern
timeFrame: 30 minutes after intervention
measure: Change of Heart Rate
timeFrame: 30 minutes after intervention
measure: Change of Peripheral Oxygen Saturation
timeFrame: Immediately and 30 minutes after intervention
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Department of Physical Therapy, Federal University of Pernambuco, Recife, Pernambuco, Brazil
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Catarina Rattes
role: PRINCIPAL_INVESTIGATOR
References: