Adventitious Lung Sounds as Indicators of Severity and Recovery of Lung Pathology and Sputum Location
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change in adventitious lung sounds
研究概览
简要总结
This study aims to assess the responsiveness to change of adventitious lung sounds (ALS) in patients with lower respiratory tract infection (LRTI).
Patients will be recruited from a central Hospital and their demographic and anthropometric data, lung sounds, lung function, breathlessness, oxygen saturation and chest HRCT scan will be collected within 24h of the first appointment. Then, patients will be randomly allocated to either conventional treatment or conventional treatment plus respiratory physiotherapy. Conventional treatment will consist on daily medical treatment prescribed by the physician. Respiratory physiotherapy will involve 9 sessions (3 times a week during 2 weeks) of breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease.
It is expected that ALS will be responsive to changes in patients' lung function after treatment. It is also expected that, by including a respiratory physiotherapy component in the treatment of patients with LRTI, they will express more improvements in a shorter period of time.
详细描述
Respiratory problems are a significant burden to patients of all ages suffering from the most different pathologies and to their respective families, with enormous economic costs. Thus, respiratory therapies, physical (such as airway clearance therapy) or chemical (such as medication or inhalation therapies) are of increasing importance. However, little is known about the effectiveness of respiratory therapies due to the lack of accuracy, reliability and sensitivity of the current outcome measures used. Adventitious lung sounds (i.e., wheezes and crackles) have been shown to be objective, reliable measure and a sensitive indicator of minor alterations in airway geometry. Using wheezes' and crackles' analysis, the detection and characterization of the severity of the lung disease may be performed before any other measure. However, studies assessing the responsiveness to change of the ALS have never been conducted and are deemed necessary to assess if ALS are an appropriate outcome measure to overcome the problems recognized in the other clinical measures.
Therefore the main aim of this project is to assess and interpret the responses of lung sounds to respiratory interventions. To achieve this aim, high resolution computed tomography (HRCT), which is the gold standard to assess lung diseases, will be performed.
The specific aims of the study are:
- to explore ALS as indicators of severity and recovery of lung disease comparing acoustic data from the lungs with lung HRCT images and with the other measures i.e. breathlessness, oxygen saturation and lung function data )pre/post respiratory treatments);
- to explore ALS data as indicators of sputum movement comparing acoustic with imaging analysis;
- to explore respiratory physiotherapy effectiveness in patients with LTRI.
The plan is to recruit approximately 100 voluntary patients with LRTI attending to casualty at a central hospital. This study will enroll adult patients diagnosed with LRTI according to the international guidelines. The age and pathology of the participants have been chosen because i) adult patients are easier to collaborate; ii) there is some characterization based on ALS of adult patients allowing future comparisons; iii) this pathology normally benefit from medical and respiratory physiotherapy treatments as soon as the diagnose is made, but in Portugal do not often received respiratory physiotherapy. Furthermore, these patients will be able to cooperate with the data collection, namely with the imaging techniques, which is fundamental to assess the responsiveness to change of a measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of LRTI according to the international guidelines (i.e., presence cough and at least one of the following symptoms: sputum, dyspnoea, wheezes or chest pain)
- •≥ 18 years old
- •able to provide their own informed consent
排除标准
- •cognitive impairments
- •inability to understand and co-operate
- •bedridden or complete dependence on a wheelchair
- •score >2 in the CURB criteria
- •presence of severe comorbidities (e.g., past history of pulmonary lobectomy and current history of neoplasia, tuberculosis or other infectious disease)
研究组 & 干预措施
Physiotherapy+conventional treatment
Patients will be treated with daily medication prescribed by the physician, during 3 weeks. Additionally, they will be involved in 9 sessions (3 times a week during 2 weeks) of respiratory physiotherapy including breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease.
干预措施: Physiotherapy+conventional treatment (Other)
Conventional treatment
Patients will be treated with daily medication prescribed by the physician, during 3 weeks.
干预措施: Conventional treatment (Drug)
结局指标
主要结局
Change in adventitious lung sounds
时间窗: 24 hours after hospital presentation (baseline) and 3 weeks after intervention
Adventitious lung sounds are sounds superimposed on the normal respiratory sound. There are continuous (wheezes) and discontinuous (crackles) adventitious sounds. The presence of adventitious lung sound generally indicates pulmonary disorders.
次要结局
- Change in exercise tolerance(assessment at baseline and 3 weeks after intervention)
- Change in activities limitation resulting from breathlessness(assessment at baseline and 3 weeks after intervention)
- Change in lung function(assessment at baseline and 3 weeks after intervention)
- Change in High Resolution Computed Tomography (HRCT scans)(assessment at baseline and 3 weeks after intervention)
- Change in peripheral oxygen saturation(assessment at baseline and 3 weeks after intervention)
研究者
Alda Sofia Pires de Dias Marques
Senior Lecturer
Aveiro University
