High-flow Nasal Oxygen Therapy to Prevent Extubation Failure in Adult Trauma Intensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Reintubation rate
研究概览
简要总结
A significant proportion of patients who are intubated for trauma-related injuries, will fail the extubation process. This means that, when the decision has been made to remove the endotracheal tube, a certain proportion of these patients will require the endotracheal tube to be re-inserted. Global estimates for the rates of re-intubation range from 5-15% of all patients who have had attempted extubation on Intensive Care Units. The exact figures for intubated victims of trauma are not available. Re-intubation is associated with increased intensive care and hospital length of stay, increased morbidity, and the physical risks to the patient inherent with the intubation process. There is also some evidence that the rates of tracheostomy are higher in patients who have failed extubation. A number of interventions have been developed to help prevent extubation failure. Non-invasive ventilation and high-flow nasal oxygen are routinely employed in practice. However, there have been no specific studies of these interventions in TICU patients. High-flow nasal oxygen therapy (HFNO) has emerged over the last decade as a viable adjunct in the management of patients suffering from, or at risk of, hypoxemic respiratory failure. Within the intensive care unit settings, HFNO has been studies in terms of preventing intubation, but it has been evaluated more often in terms of preventing extubation failure.
Our study aims to answer the question of whether HFNO is effective at preventing extubation failure in intubated and ventilated victims of traumatic injuries. Previous studies on the same subject, are not based on unequivocal, robust RCTs with low risk of bias. Our primary outcome measure is re-intubation rates and secondary outcome measures are CO2 accumulation rates, atelectasis rates, nutrition status within first 24 hours post extubation, and post - extubation rates of vomiting. Ours will be a prospective, randomized clinical control study. There will be three arms to the study: a control arm, and two intervention arms. Randomization will be done on a permuted block basis. The control arm will be patients receiving standard oxygen therapy, and the intervention arms will be either High Flow Nasal Oxygen Therapy or Non-invasive Ventilation via mask. We propose that, when compared with either face-mask O2, NIV (CPAP), HFNO administered continuously for 24 hours post extubation of trauma patients on ICU, will result in better patient-related outcomes.
详细描述
High-flow nasal oxygen therapy (HFNO) has emerged over the last decade as a viable adjunct in the management of patients suffering from, or at risk of, hypoxemic respiratory failure. The mechanisms of its therapeutic benefit are not precisely understood but are thought to include a small but significant continuous positive airway pressure effect, and in the context of critically ill patients, the use of HFNO has been studied for the prevention of intubation, or as an alternative to Noninvasive Ventilation (NIV) for the prevention of intubation, in Type I respiratory failure patients, mostly with COPD or Heart Failure. Within the intensive care unit itself, HFNO has been studies in terms of preventing intubation, but it has been evaluated more in terms of preventing extubation failure. However, there have been no specific studies in Trauma Intensive Care Unit (TICU) patients. Patients suffering with polytrauma, who survive to TICU admission, are a unique population. There is a significant incidence of confusion and/or delirium post-extubation. In patients with respiratory failure post extubation, it is postulated (1) that the impaired mental state, however mild, may cause patients to a) be unable to tolerate NIV, b) swallow more air (on NIV) due to mild bulbar dysfunction, thus leading to an increased risk of regurgitation and possible aspiration pneumonitis. Furthermore, the use of NIV may c) impair effective oral nutrition in those patients without an NJ tube placed.
Re-intubation (failed extubation) is defined variably as the need to intubate a patient within 72 hours of extubation in the critical care unit. Re-intubation is associated with increased intensive care and hospital length of stay, increased morbidity, and the physical risks to the patient inherent with the intubation process. It is unclear which, if any, interventions can help reduce the rate of extubation failure in Trauma Intensive Care patients.
In this research study we are focusing on HFNO compared with NIV and conventional oxygen therapy in trauma patients to avoid reintubation.
We propose that, when compared with either face-mask oxygen, NIV (CPAP), HFNO administered continuously for 24 hours post extubation of trauma patients on ICU, will result in better patient-related outcomes.
Primary outcome measure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will be unaware of the intervention. Data analysis performed independently to assess outcome variables
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
- •Adult intubated and ventilated patients who are victims of trauma and are being cared for on the Trauma Intensive Care Unit will be considered eligible for the study when they are considered fit for extubation.
排除标准
- •Patients who cannot be extubated (including patients requiring tracheostomy)
- •Patients with cribriform plate fractures
- •Patients with nasal occlusion for any reason
- •Patients with unstable mid-face fractures
结局指标
主要结局
Reintubation rate
时间窗: 72 hours
How many patients who have experienced extubation require re-intubation.
次要结局
- Nutritional intake achieved(24 hours post extubation)
- Amount of carbon dioxide retention(24 hours post extubation)
- Post extubation rates of vomiting(24 hours)
