Aerosol Therapy With High Flow Nasal Cannula (HFNC) in Obese COPD Patients. Aerosol Deposition Pattern and Predictive Values.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pattern of aerosol lung deposition.
研究概览
简要总结
This study has the objective to clarify the factors that directly influence the effectiveness of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease (COPD) and suggest the use of High Flow Nasal Cannula (HFNC) during their inhalation therapy.
详细描述
This study has the objective to clarify the factors that directly influence the effectiveness of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease (COPD) and then formulate specific strategies to control the evolution of this disease. The suggested strategy in order to implement the aerosol therapy is the use of High Flow Nasal Cannula (HFNC) during these patient´s inhalation therapy.
It will consist in a cross-over clinical trial. The population will be composed by volunteers of both genders, aged between 45-70 years old. Four distinct groups will be formed: obese participants without copd; obese participants with copd; non obese participants without copd; non-obese participants with copd.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HEALTHY, non obese
- •no history of respiratory disease
- •non smokers
- •self declared sedentary
- •Forced expiratory volume at first second (FEV1) equal or higher than 80% of predicted
- •Forced Vital capacity (FVC) equal or higher than 80% of predicted;
- •FEV1/FVC higher than 70% of predicted.
- •BMI lower than 30 kg/m2
- •HEALTHY, obese
- •no history of respiratory disease
- •non smokers
- •self declared sedentary
- •Forced expiratory volume at first second (FEV1) equal or higher than 80% of predicted
- •Forced Vital capacity (FVC) equal or higher than 80% of predicted
- •FEV1/FVC higher than 70% of predicted.
- •BMI equal or higher than 30 kg/m2
- •COPD participants, non obese
- •ex smokers
- •clinical stability (six previous weeks)
- •FEV1 lower than 80% of predicted.
- •FEV1/FVC lower than 70 % post bronchodilator.
- •No cardiopulmonary diseases (self declared)
- •BMI lower than 30 kg/m2
- •COPD participants, obese
- •ex smokers
- •clinical stability (six previous weeks)
- •FEV1 lower than 80% of predicted.
- •FEV1/FVC lower than 70 % post bronchodilator.
- •No cardiopulmonary diseases (self declared)
- •BMI equal or higher than 30 kg/m2
排除标准
- •Difficulty to understand verbal commands
- •exacerbations during the study period
结局指标
主要结局
Pattern of aerosol lung deposition.
时间窗: during the following 25 minutes post inhalation protocol
The pattern of aerosol lung deposition will be compared between obese and non obese participants (with and without COPD) as well as between inhalation with HFNC and without HFNC
次要结局
- Change of pulmonary function after bronchodilators administration. (with and without HFNC)(Change from Baseline Pulmonary Function at 5 minutes after scintigraphy.)
- Muscle Mass(first day of study)
- BMI(first day of study)
- Upper airways anatomical variables CT scans(first day of study)
- Mallampati Score(first day of study)
- Body fat(first day of study)
研究者
Taciano Dias de Souza Rocha
Master in Physiotherapy
Universidade Federal do Rio Grande do Norte