Effect of the Use of Protective Masks on the Ability to Perform Daily Activities in Patients with Heart Failure or Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of differences in ventilation expressed as L/min
研究概览
简要总结
Scientific Rationale: In late 2019 and early 2020, researchers at the Wuhan Institute of Virology identified a potential new etiologic agent, called new coronavirus 2019 (nCoV-2019). Subsequently, the epidemic unleashed by this virus involved the whole world and radically changed the habits of the entire global population. Since that time, in fact, the need to contain the spread of infection through specific social distancing procedures and through the use of personal protective equipment has become compelling. The main tool was the requirement for all citizens to wear masks for airway protection. This measure has thus become in daily use for the majority of the population.
Therefore, it has become increasingly important to evaluate the impact of mask wearing on activities of daily living (ADls), both in healthy subjects, for which several evidences have already been brought, and in patients with different diseases, for which data are still insufficient to fully describe the effects.
Oxygen consumption and dyspnea during simple activities of daily living (ADLs) have already been studied in patients with heart failure (HF) and chronic obstructive pulmonary disease (COPD), and there is evidence that these subjects compared with healthy subjects perform ADLs at a higher percentage of their peak VO2 with more dyspnea. However, there are still no studies highlighting, however, the consequences of performing such activities while wearing a protective filtering facepiece particles class 2 (FFP2) mask, to date considered the most suitable to preserve the most fragile subjects from infection.
In this study, therefore, the investigators aim to asess the effects of these devices on the ability to perform ADLs by evaluating the exchanges of respiratory gases in the body during the performance of normal activities or during sleep in patients with HF or COPD compared with healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects:
- •Age: 18-80 years
- •Not taking cardiovascular medications
- •No history of cardiovascular disease
- •Normal physical examination
- •Normal ECG
- •Inclusion criteria for subjects with HF:
- •Age: 18-80 years
- •New York Heart Association Class (NYHA) II to III in stable clinical condition
- •Left ventricular ejection fraction (LVEF) <40%
- •Ability to perform a maximal CPET
- •Patients with COPD:
- •Age: 18-80 years
- •Diagnosis of COPD stage GOLD II-III in stable clinical condition
- •Absent concomitant heart disease
- •Ability to perform a maximal CPET
排除标准
- •Healthy subjects:
- •Presence of concomitant diseases
- •Oxygen therapy
- •Inability or contraindication to perform a maximal CPET
研究组 & 干预措施
Wearing mask
Subjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities while wearing a protective mask
干预措施: Respiratory protective mask (Device)
Not wearing mask
Subjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities in basal conditions
结局指标
主要结局
Evaluation of differences in ventilation expressed as L/min
时间窗: 2 weeks
Differences in ventilation (VE) in different daily activities under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.
Evaluation of differences in VO2 expressed in mL/min/kg
时间窗: 2 weeks
Differences in oxygen consumption (VO2) in different daily activities under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.
次要结局
- Evaluation of differences in heart rate (beats/min)(2 weeks)
- Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal hypopnea (number of events)(2 weeks)
- Evaluation of differences in VE/VCO2 (slope during the exercise)(2 weeks)
- Evaluation of differences in nocturnal desaturation (%)(2 weeks)
- Evaluation of differences in peripheral saturation (%)(2 weeks)
- Evaluation of differences in dyspnea (Borg scale)(2 weeks)
- Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal apneas (number of events)(2 weeks)