Value of Incentive Spirometry in Routine Management of COPD Patients and Its Effect on Diaphragmatic Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- assessing the change in baseline percentage of diaphragmatic thickness fraction
研究概览
简要总结
The incentive spirometer is a device that encourages patients, with visual and other positive feedback, to maximally inflate their lungs and sustain that inflation. However, its efficacy in patients with COPD has been little documented especially in diaphragmatic function. This study tried to assess the role of incentive spirometry on Spirometric functions, Sonographic diaphragmatic function, and the scale of dyspnea in COPD patients with exacerbation and with follow-up of these parameters after 2 months.
详细描述
Forty COPD patients were admitted with an acute exacerbation and the patients were divided randomly into 2 equal groups: the first used the incentive spirometer together with medical treatment (according to GOLD guidelines) for 2 months and the second received only medical treatment for 2 months. All participants, on admission, underwent assessment of mMRC dyspnea scale, spirometry, arterial blood gases, and diaphragmatic ultrasound. Then, a follow-up of the participants was done after 2 months with the same parameters and a comparison between both groups was done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed cases of COPD according to the criteria GOLD
- •age more than 40 years
排除标准
- •bad acoustic window by ultrasound
- •other chronic respiratory diseases
- •lung malignancy
- •recent major surgery
- •inability to complete or perform the study
- •patient refusal
研究组 & 干预措施
group 1
participants would use incentive spirometry for 2 months together with ordinary medical treatment
干预措施: incentive spirometry (Device)
group 2
participants would receive only ordinary medical treatment for 2 months
结局指标
主要结局
assessing the change in baseline percentage of diaphragmatic thickness fraction
时间窗: 2 months
assessing the change from baseline percentage of diaphragmatic thickness fraction (%) using ultrasound to 2 months
change in arterial blood gases
时间窗: 2 months
assessment the change in baseline PaO2 and PaCO2 (in mmHg) to 2 months
assessing the change in baseline diaphragmatic excursion in cm
时间窗: 2 months
assessing the change from Baseline diaphragmatic excursion (in cm) using ultrasound to 2 months
assessing the change in baseline peak expiratory flow rate percentage
时间窗: 2 months
assessing the change from baseline peak expiratory flow rate percentage (%) using spirometry to 2 months
assessing the change in baseline forced vital capacity percentage of predicted
时间窗: 2 months
assessing the change from baseline forced vital capacity percentage of predicted (%) using spirometry to 2 months
assessing the change in baseline forced expiratory volume in 1st second/forced vital capacity percentage (%)
时间窗: 2 months
assessing the change from baseline forced expiratory volume in 1st second/forced vital capacity percentage (%) using spirometry to 2 months
assessing the change in mMRC dysnea scale
时间窗: 2 months
assessing the change in the severity of dyspnea by mMRC dysnea scale from baseline to 2 months. It is 5 statements giving grades from 0 to 4 with the higher the degree, the more severe the shortness of breath in patients with COPD
次要结局
未报告次要终点
研究者
Amal A. El-Koa
doctor
Menoufia University