Different Positive Pressure Strategies in COPD Patients.

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Nebulization; Device: Positive expiratory pressure valve; Device: Nonivasive ventilation

• Registration Number: NCT03382197
• Lead Sponsor: Universidade Federal de Pernambuco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-22
• Study Start: 2018-01-01
• Primary Completion: 2018-03-16
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-07-31
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nebulization	Nebulization	control intervention, will only perform nebulization;
Positive expiratory pressure valve	Positive expiratory pressure valve	Intervention, will perform nebulization associated with positive expiratory pressure valve in the airways (EPAP)
Nonivasive ventilation	Nonivasive ventilation	intervention, will perform nebulization associated with non-invasive ventilation Bi-level mode;

Primary Outcome Measures

Name	Time	Method
Change of Pulmonary Function	30 minutes after intervention	Pulmonary function test performed through spirometry
Change of Regional pulmonary ventilation	30 minutes after intervention	The impedance variation (AZ) and regional pulmonary ventilation (ZEE) will be evaluated for each region of interest.
Change of Aerosol deposition in the lungs	Immediately after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Change of Peripheral Oxygen Saturation	Immediately and 30 minutes after intervention	Peripheral Oxygen Saturation
Change of Heart Rate	30 minutes after intervention	Heart Rate
Change of Ventilatory pattern	30 minutes after intervention	Respiratory rate, tidal volume, minute volume, inspiratory time, expiratory time, and total time.

Trial Locations

Locations (1)

Department of Physical Therapy, Federal University of Pernambuco, Recife, Pernambuco, Brazil; 🇧🇷 Recife, Pernambuco, Brazil