Comparison of Protective Manual Hyperinflation With Current Methods in Ventilated Acute Trauma Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Interleukin 6
研究概览
简要总结
This single-blinded randomized study aims to compare two methods of manual hyperinflation (protective - moderate tidal volumes with positive end expiratory pressure) and non-protective (large tidal volume and no positive end expiratory pressure) in ventilated acute trauma patients, to investigate the effect on inflammatory markers, lung compliance, oxygenation and sputum volume.
详细描述
Current evidence in mechanical ventilation supports a "protective lung strategy" that is, smaller tidal volumes and prevention of loss of positive end expiratory pressure (PEEP). There is concern that manual hyperinflation (MHI) may conflict with this strategy and cause volutrauma and atelectrauma potentially leading to biotrauma.
This single-blinded randomized study aims to compare two methods of manual hyperinflation (protective - moderate tidal volumes with positive end expiratory pressure) and non-protective (large tidal volume and no positive end expiratory pressure) in ventilated acute trauma patients, to investigate the effect on inflammatory markers, lung compliance, oxygenation and sputum volume.
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
- Double (Participant, Outcomes Assessor)
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
- •Trauma patients
- •Day 1 of admission to intensive care
- •Mechanically ventilated
排除标准
- •Pre-existing lung disease
- •PEEP > 12.5cmH20
- •Nitric oxide in circuit
- •Haemodynamically unstable
- •Undrained pneumothorax
- •Intracranial pressure > 25mmHg
结局指标
主要结局
Interleukin 6
时间窗: Change between Baseline and 40 minutes and 70 minutes post baseline
5 mls of arterial blood will be colected in an EDTA tube, centrifuged and aliquoted within 30 minutes. It will be stored at -80 degrees C and the analysis completed in batches by enzyme linked immunosorbent assay
次要结局
- Tumour necrosis factor alpha(Change from Baseline to 40 minutes and 70 minutes post baseline)
- Interleukin 1-beta(Change between baseline and 40 minutes and 70 minutes post baseline)
- Interleukin 8(Change between baseline and 40 minutes and 70 minutes post baseline)
- PaO2/FiO2 Oxygenation ratio(Chnge between baseline and 15 minutes and 40 minutes post baseline)
- Static lung compliance(Change between Baseline and 15 minutes and 70 minutes post baseline)
- Mean arterial blood pressure(the change between baseline and every minute during intervention for 10 minutes will be compared)
- Sputum volume(Immediately at end of intervention)