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临床试验/NCT03382197
NCT03382197Unknown不适用

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

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Change of Pulmonary Function

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Two experienced researchers will participate in the study, one being responsible for the evaluation of the outcomes (researcher 1) and the other responsible for the application of the intervention in each patient (researcher 2). The researcher 2 will receive in opaque and sealed envelopes the randomized order of the interventions of each patient, keeping them in secrecy until the end of the whole study.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Nebulization

Experimental

control intervention, will only perform nebulization;

干预措施: Nebulization (Device)

Positive expiratory pressure valve

Experimental

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

干预措施: Positive expiratory pressure valve (Device)

Nonivasive ventilation

Experimental

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

干预措施: Nonivasive ventilation (Device)

结局指标

主要结局

Change of Pulmonary Function

时间窗: 30 minutes after intervention

Pulmonary function test performed through spirometry

Change of Regional pulmonary ventilation

时间窗: 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

时间窗: 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.

次要结局

  • Change of Peripheral Oxygen Saturation(Immediately and 30 minutes after intervention)
  • Change of Heart Rate(30 minutes after intervention)
  • Change of Ventilatory pattern(30 minutes after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catarina Souza Ferreira Rattes Lima

Principal Investigator

Universidade Federal de Pernambuco

研究点 (2)

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