Impact of Intermediate Normal Compared to High Normal Oxygen Levels on Outcomes of Patients Presenting in the Emergency Department With Severe Traumatic Brain Injury (INACHOS): a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Mean area-under-curve (AUC) for SpO2
研究概览
简要总结
Despite almost universal usage of supplemental oxygen therapy in patients presenting in the emergency department with traumatic brain injury (TBI), optimal oxygen levels are unclear.
The investigators propose a pilot multi-center randomized controlled trial to test the hypothesis that maintaining intermediate normal as opposed to high normal oxygen levels in patients presenting in the emergency department with TBI is feasible, and to obtain preliminary data on the efficacy of the two approaches to oxygen therapy. The aim is that the investigators produce pilot data, which could inform the design of potential subsequent larger clinical trials.
详细描述
Despite the worldwide burden of traumatic brain injury (TBI), medical research on the field as opposed to other health problems is underrepresented. Consequently, there are few data to support commonly used interventions for the management of TBI, especially in the setting of the emergency department. For example, despite almost universal usage of supplemental oxygen therapy, the effects of different oxygenation levels under normobaric conditions on outcomes of patients presenting in the emergency department with TBI are unknown.
On the one hand, liberal oxygenation may provide a margin of safety against hypoxemia and may be needed to meet the high oxygen demands of an acutely altered brain physiology. On the other hand, there are increasing concerns that excessive oxygen supplementation may have harmful effects, such as central nervous system toxicity, cerebral vasoconstriction, impaired immunity leading to predisposition to infections (including pneumonia) and acute lung injury/acute respiratory distress syndrome. Such effects could be avoided by intermediate normal oxygen levels.
Taken together, the relative merits and risks of the abovementioned two approaches to oxygen therapy (namely, intermediate normal versus high normal oxygen levels) of patients with TBI in terms of important clinical outcomes (namely, development of nosocomial pneumonia, acute respiratory distress syndrome, disability and mortality) remain undefined. This suggests the need for randomized controlled trials. However, randomized controlled trials focusing on patient-centered outcomes should be preceded by pilot randomized controlled trials, which demonstrate a separation in treatment and protocol compliance (feasibility) associated with the studied interventions.
Therefore, the investigators propose a pilot multi-center randomized controlled trial to test the hypothesis that maintaining intermediate normal as opposed to high normal oxygen levels in patients presenting in the emergency department with TBI is feasible, and to obtain preliminary data on the efficacy of the two approaches to oxygen therapy.
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)
盲法说明
To avoid selection bias, the allocation sequence will be blinded from researchers involved in patient enrolment. Although study subjects will be unaware of the assigned group, blinding of treating clinicians is not considered feasible.
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 patient ≥18 years
- •Glasgow Coma Scale ≤ 8
- •Non-penetrating traumatic brain injury
- •Intubated patient
排除标准
- •Age <18 years
- •Lack of intention to admit to the intensive care unit
- •Moribund patient expected to die within 24 hours
- •Expected need for mechanical ventilation < 24 hours
- •Time interval from intubation to group allocation more than 60 minutes
- •Penetrating traumatic brain injury
- •Pregnancy
- •Lack of equipoise of the treating clinician
- •Lack of informed consent
研究组 & 干预措施
High normal oxygen
For the "high normal oxygen" group, an oxygen saturation by pulse oximetry (SpO2) of 99-100% will be recommended. The lower-limit monitor alarm for SpO2 will be set at 98%. No upper alarm limit for SpO2 will be set.
In case that the emergency department of a study site uses ventilators, which allow for only two options of FiO2 titration (namely, "air mix" and "FiO2 of 1.0"), then the "high normal oxygen" group should receive "FiO2 of 1.0".
干预措施: Oxygen (Other)
Intermediate normal oxygen
For the "intermediate normal oxygen" group, an oxygen saturation by pulse oximetry (SpO2) of 95-97% will be recommended in the light of the Improving Oxygen Therapy in Acute-illness (IOTA) meta-analysis. The acceptable lower limit of PaO2 will be set to 80 mmHg according to a recent consensus of experts endorsed by the European Society of Intensive Care Medicine. The lower-limit and higher-limit monitor alarm for SpO2 will be set at 94% and 98%, respectively.
In case that the emergency department of a study site uses ventilators, which allow for only two options of FiO2 titration (namely, "air mix" and "FiO2 of 1.0"), then the "intermediate normal oxygen" group should receive "air mix".
干预措施: Oxygen (Other)
结局指标
主要结局
Mean area-under-curve (AUC) for SpO2
时间窗: Measurements will be obtained each hour for a total duration of 6 hours from intubation.
SpO2 will be recorded each hour for a total duration of 6 hours from intubation. Subsequently, mean area-under-curve (AUC) will be calculated for each group. This will demonstrate the feasibility of the study.
Mean area-under-curve (AUC) for FiO2
时间窗: Measurements will be obtained each hour for a total duration of 6 hours from intubation.
FiO2 will be recorded each hour for a total duration of 6 hours from intubation. Subsequently, mean area-under-curve (AUC) will be calculated for each group. This will demonstrate the feasibility of the study.
PaO2
时间窗: Measurements will be obtained at least once during 6 hours from intubation.
PaO2 will be recorded at least once during 6 hours from intubation. Subsequently, PaO2 values (mmHg) will be calculated for each group. This will demonstrate the feasibility of the study.
次要结局
- Acute Respiratory Distress Syndrome (ARDS)(Within 7 days of subject enrollment)
- All-cause mortality(Within 28 days of subject enrollment)
- Nosocomial pneumonia(Within 7 days of subject enrollment)
- Extended Glasgow Outcome Score (GOS-E)(At 6 months following subject enrollment)
研究者
Ilias Siempos
Academic Scholar
Evangelismos Hospital