Efficacy and Ventilatory Responsiveness of Ventilator Hyperinflation Technique to Re-expand Lung Atelectasis and Improved Airway Clearance on Patients With Critical Trauma Who Are Intubated and Mechanically Ventilated
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Baseline in Chest Radiography
研究概览
简要总结
The purpose of this study include (1) To investigate the efficacy of ventilator hyperinflation technique to re-expand lung atelectasis on patients with critical trauma who intubated and mechanical ventilation in the intensive care unit, (2) To investigate the effectiveness of ventilator hyperinflation technique to improve airway clearance on patients with critical trauma in the intensive care unit, and (3) To explore the acute responses of ventilatory functions to ventilator hyperinflation technique on patients with critical trauma who intubated and mechanical ventilation in the intensive care unit.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critical trauma patients with pulmonary complications who were intubated and mechanical ventilation and have a diagnosis of lobar atelectasis and/or plate-like atelectasis (atelectasis demonstrated on chest X-ray) will be considered for inclusion. For the sign of plate-like atelectasis will be persist on chest X-ray for 2 day
- •The injuries may occur alone or combination of these injuries: 1) head injury, 2) chest injuries, including broken ribs, with or without hemothorax, pneumothorax and hemopneumothorax with intercostal chest drainage (ICD), 3) blunt abdominal, and 4) fracture of the limbs and/or spine.
排除标准
- •acute respiratory distress syndrome (ARDS)
- •acute lung injury (ALI)
- •pulmonary contusion
- •undrained pneumothorax, hemothorax, and hemopneumothorax
- •bronchospasm
- •pulmonary bullae/blebs
- •lung tumors
- •lung abscess
- •haemoptysis
- •mean arterial pressure (MAP) <70 mmHg
- •positive end expiratory pressure (PEEP) >6 cmH2O
- •heart rate (HR) >140 beats/min
- •blood pressure (BP) <90/60 or >180/100 mmHg
- •restlessness
- •oxygen saturation (SpO2) <90%
- •spontaneous respiratory rate (RR) >35 beats/min
研究组 & 干预措施
Control group
All of the participants in control group will be treated with conventional treatment for 3 days, The conventional treatments consist of: (1) Passive chest mobilization, (2) Positioning, (3) Side lying (good lung down), (4) Vibration. The conventional treatment consists of three consecutive periods; (1) baseline period: 10 minutes, (2) intervention period, and (3) recovery period: 10 minutes.
干预措施: Conventional treatment (Procedure)
Experimental group
All of the participants of the experimental group will be treated with ventilator hyperinflation technique (VHI) for 3 days. Tidal volume will increase from baseline (100% VT) to the tidal volume target at 1.5 times (150% VT). At this level, patients will receive six breathes and in each breathe will be sustained for 5 second (6 hyperinflation breathe per set); expiratory VT will return to baseline after each breath. Four sets of hyperinflation breathing will be used. After this, VT will decrease to baseline and patients have a 60 second for rest between hyperinflation set. The ventilator hyperinflation technique (VHI) consists of three consecutive periods; (1) baseline period: 10 minutes, (2) intervention period, and (3) recovery period: 10 minutes.
干预措施: Ventilator hyperinflation technique (Procedure)
结局指标
主要结局
Change from Baseline in Chest Radiography
时间窗: "Change from Baseline in Chest Radiography at Day 1 after Received Intervention (VHI)" and "Change from Baseline in Chest Radiography at Day 3 after Received Intervention (VHI)"
The study took three day, chest radiography will be taken at 2 day before the study begin (first film; base line) and after day 1 (second film) and day 3 of the study (third film). Any improvement will be assessed by comparing the second and the third film to the first film by a radiologist who will be blinded to the treatment given. Atelectasis will grade using the following rating scale: 0 = no atelectasis; 1 = plate-like atelectasis; 2 = mild lobar collapse; 3 = moderate lobar collapse; and 4 = complete lower lobar collapse. Separate results will comply for the left and right lungs.
次要结局
- Change from baseline in respiratory rate (RR) at during and end of ventilator hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
- Change from baseline in tidal volume (VT) at during and end of ventilator hyperinflation technique (VHI)hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
- Change from baseline in minute ventilation (VE) at during and end of ventilator hyperinflation technique (VHI)technique (VHI)hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
- Change from baseline in peak inspiratory pressure (PIP) at during and end of ventilator hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
- Change from baseline in oxygen saturation (SpO2) at during and end of ventilator hyperinflation technique (VHI)hyperinflation technique (VHI)technique (VHI)hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
- Change from baseline in dynamic lung compliance (Cdyn) at during and end of ventilator hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
- Change from baseline in end-tidal pressure of carbon dioxide (PETCO2) at during and end of ventilator hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
- Change from baseline in arterial blood gases (ABG) at end of ventilator hyperinflation technique (VHI)(Within one hour before VHI and 10 minute after VHI.)
- 24 hour sputum collection(The secretion will be collected 24 hours in each day.)
- Clearance index(Sputum content that collects at 08.30 and 09.35 will test by cough transportability method and compare between time point for represent the clearance index (at 08.30 for pre-intervention period and at 09.35 for post-intervention period).)
研究者
Guntaragorn Hongrattana
school of physical therapy, faculty of associated medical sciences
Khon Kaen University