Effects Of Noninvasive Ventilation During The Treadmill Walking Test On Cardiorespiratory System, Walk Distance, And Thoracoabdominal Kinematics Of Patients With Cystic Fibrosis: Clinical Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Walk Distance (WD) on six minute walk test (6MWT)
研究概览
简要总结
The purpose of this study is to evaluate the effect of noninvasive ventilation (NIV) in functional capacity of children and adolescents with cystic fibrosis.
详细描述
This is an open randomized controlled crossover clinical trial. Sample selection was by convenience and patients were screened at the Pneumology outpatient facility of the Instituto de Medicina Integral Professor Fernando Figueira (IMIP) in Recife, Brazil.
The sample was calculated using a software developed by the MGH Mallinckrodt General Clinical Research Center, based on the results of the first 10 volunteers, for a statistical power of detecting differences between procedures of 80% and a significance level of 0.05. A sample size of n=13 patients was determined, considering that the real difference between the walk distance between procedures with and without NIV is 0.03 km and the standard deviation of the differences in variables is 0.034 km.
All patients agreed to take part in the study by giving their informed consent, in accordance with resolution 196/96 of the National Health Council.
Technical Procedures Patients were initially assessed for current and past conditions, medication use and anthropometric data (height, weight and body mass index - BMI). Next, a randomized plan was compiled using the Web Site Randomization.com, applying a generator of random-permuted blocks to define the order in which patients would execute the 6MWT, with or without NIV. Patients allocated to group 1 (G1) initiated the 6MWT without NIV to subsequently perform the test with ventilatory support, since those allocated to group 2 (G2) underwent the tests in reverse order. A minimum and maximum rest period of 24 and 48 hours, respectively, was observed between tests.
Before and after the 6MWT with and without NIV, patients were assessed for variations in compartmental chest wall volume and ventilatory pattern by optoelectronic plethysmography (OEP), which was followed by the spirometric test. A 20-minute rest period was given after the pulmonary function test before proceeding to the 6MWT.
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
- None
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of Cystic Fibrosis
- •FEV1< 80% of predicted
- •age between 7 and 16 years
- •clinically stable patients
- •no history of hospitalization for respiratory failure in the last three months
排除标准
- •recent history of hemoptysis
- •pneumothorax or evidence of emphysomatous bubbles detected by chest X-ray
- •Burkholderia cepacia colonization
- •the need for more than two physiotherapy sessions per day
- •gastroesophageal reflux
- •orthopedic trauma or cardiovascular conditions that impede the treadmill walk test
- •heart failure
结局指标
主要结局
Walk Distance (WD) on six minute walk test (6MWT)
时间窗: 2 days
Patients allocated to group 1 (G1) initiated the 6MWT without noninvasive ventilation (NIV) to subsequently perform the test with ventilatory support, since those allocated to group 2 (G2) underwent the tests in reverse order. Rest period between tests: 24 - 48 hours. At the end of the test, the walk distance on a treadmill is recorded.
次要结局
- Forced vital capacity (FVC)(2 days)
- Forced expiratory flow of 25% to 75% of FVC (FEF 25-75)(2 days)
- Respiratory cicle time(2 days)
- Forced expiratory volume in the first second (FEV1)(2 days)
- Rib cage volumes(2 days)
研究者
Cibelle Andrade Lima
Master - Universidade Federal de Pernambuco
Universidade Federal de Pernambuco