Study of Breathing Exercise With Oscillated Inspiratory Loading (OIS) and Oscillated Positive Expiratory Pressure (OPEP) for Airway Secretion Clearance and Lung Function in Intubated Patients, Both With and Without Mechanical Ventilatory Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- change from baseline in secretion wet weight (gram) between 3 hours before and after breathing exercise program
研究概览
简要总结
The efficacy of breathing exercise with oscillated inspiratory loading and oscillated positive expiratory pressure for airway secretion clearance and lung function in intubated patients, both with and without mechanical ventilation dependence
详细描述
Effective strategies to increase mucus clearance rate has been suggested to depend on 4 factors.
- Oscillation at proper frequency.
- Lung volume and airway opening.
- Expiratory flow rate or expiratory bias.
- Humidifying of inspired air.
Multifunctional breathing device, the BreatheMAX, is the only breathing device made in Thailand. The BreatheMAX device possess many properties or techniques that benefit for respiratory care particularly 3 in 4 mechanisms for secretion clearance. The unique important aspect is the simultaneously providing several beneficial effects in one breath which are 1) Oscillation in the range of ciliary beat frequency 2) Biofeedback of respiratory effort that could encourage the deeper breathing performance, 3) Humidifier of inspired air, 4) Loaded breathing for inspiratory muscle training and generate PEP. These 4 functions would be very useful for increase secretion clearance particularly in more peripheral airway which are the most difficult to be cleared and be a risk of atelectasis and infection in patients with MV whose natural secretion clearance mechanisms are compromised, respiratory muscle weakness weak and low immunity.
Therefore, the combination of inspiratory and expiratory breathing exercise through the BreatheMAX breathing device may increase or promote more secretion clearance and improve lung function than expiratory breathing exercise alone in intubated patients, both with and without mechanical ventilation dependence
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following
- •Clinical and radiologic diagnosis of pulmonary infection
- •Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound
- •Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data
- •Stable of hydration status or positive fluid balance at least 2 days before collects the data
- •Ability to breathe or tolerate spontaneously breathing trial with T-piece at least 2 minutes with fraction of inspired oxygen less than 0.4 and without developing hypoxemia
- •Good conscious and well cooperation
排除标准
- •Pneumothorax (nontreated)
- •Massive hemoptysis
- •Acute myocardial infarction (with angina chest pain)
- •High intracranial pressure (>20 mm Hg)
- •Major arrhythmia
研究组 & 干预措施
BreatheMAX (OPEP)
for 10 breathes/set, 10 sets/day and rest 1 minute between set
干预措施: BreatheMAX (OPEP) (Device)
BreatheMAX (OIS and OPEP)
for 10 breathes/set, 10 sets/day and rest 1 minute between set
干预措施: BreatheMAX (OIS and OPEP) (Device)
BreatheMAX (unload and non-oscillated)
inspiratory and expiratory breathing exercise for 10 breathes/set, 10 sets/day and rest 1 minute between set
干预措施: BreatheMAX (unload and non-oscillated) (Device)
结局指标
主要结局
change from baseline in secretion wet weight (gram) between 3 hours before and after breathing exercise program
时间窗: the secretion will be collected between 3 hours before start breathing exercise program and 3 hours after end of breathing exercise program in each day
The mucus secretion will be collected by nursing staff using sterile suctioning technique via tracheostomy (TT) or endotracheal (ET) tube, without adding any saline or sterile water, the timing of suction procedure depend on the secretion sound in the ET and TT tube.
次要结局
- change from baseline in slow vital capacity (SVC) at end of breathing exercise program(within 30 minutes before breathing exercise and 30 minute after breathing exercise)
- change from baseline in lung sound at the end of breathing exercise program(within 30 minutes before breathing exercise and 30 minute after breathing exercise)
- change from baseline in heart rate at the end of breathing exercise program(5 minutes before breathing exercise and during breathing exercise and 5 minute after breathing exercise)
- change from baseline in blood pressure at the end of breathing exercise program(5 minutes before breathing exercise and 5 minute after breathing exercise)
- change from baseline in peak inspiratory pressure (PIP) at end of breathing exercise program(within 30 minutes before breathing exercise and 30 minute after breathing exercise)
- change from baseline in expired minute ventilation (VE) at end of breathing exercise program(within 30 minutes before breathing exercise and 30 minute after breathing exercise)
- change from baseline in partial pressure of oxygen saturation at the end of breathing exercise program(5 minutes before breathing exercise and during breathing exercise and 5 minute after breathing exercise)
- change from baseline in respiratory rate at the end of breathing exercise program(5 minutes before breathing exercise and during breathing exercise and 5 minute after breathing exercise)
- change from baseline in dynamic compliance (Cdyn) at end of breathing exercise program(within 30 minutes before breathing exercise and 30 minute after breathing exercise)
- change from baseline in Rating of Perceived Exertion (RPE) and Rating of Perceived Breathlessness (RPB) at the end of breathing exercise program(within 30 minutes before breathing exercise and 30 minute after breathing exercise)
研究者
Sujittra Kluayhomthong
123 Moo 16 Mittapap Road Nai-Muang, Muang District Khon Kaen 40002, Thailand
Khon Kaen University