Restrictive vs. Liberal Oxygen Therapy for Trauma Patients. PILOT: The TRAUMOX Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Composite Primary Outcomes
研究概览
简要总结
The objective of this trial is to investigate whether treatment with oxygen in the early phases after a trauma plays a role in recovery.
详细描述
Oxygen is probably the most frequently used drug both in the prehospital and emergency setting. It is cheap, easily administered, and, at least for shorter time frames, widely believed to be without any risk of harm.
Treatment with oxygen is indicated in the state of hypoxemia in order to prevent hypoxic organ damage, however, oxygen is administered in many other situations too, sometimes in a non-consistent manner and very often without even being prescribed.
Notably, administration of un-titrated oxygen, introduces a risk of hyperoxia which has been associated with serious adverse effects.
Retrospective studies on patients with cardiac arrest, myocardial infarction (MI) and traumatic brain injury have found hyperoxia to be associated with increased mortality and ICU length of stays.
A randomized trial also found an increased rate of recurrent myocardial infarction in a high-concentration oxygen group. Furthermore, in patients undergoing surgery, high intraoperative FiO2 has been associated with major respiratory complications and with 30-day mortality. In ICU patients, an observational study as well as a randomized trial found high levels of oxygen to be associated with higher mortality compared to conservative oxygen treatment. In particular, the randomized trial found that patients with PaO2 between 70 and 100 mmHg had a mortality of 11.6% compared to 20.2% in patients managed in accordance with standard ICU practice (which allows PaO2 up to 150mmHg) (p=0.01).
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
- Single (Outcomes Assessor)
盲法说明
The study will be an open-label randomized clinical trial with regards to treatment: treating staff will be aware of the patient's randomization group.
Outcome assessors (attending anesthesiologist for pneumonia and research assistant for long term outcomes (GOSE after 30 days, ARDS* within 30 days, pneumonia diagnosed after discharge within 30 days)) will be blinded to the patients' randomization.
To ensure blinding, prior to assessing the outcomes, all information indicative of the allocation will be censured by the PI.
To validate the blinding, the attending anesthesiologist and research assistant assessing outcome variables will be asked to guess which group of randomization the patient is in.
ARDS: PaO2/FiO2 will be calculated for the assessor in order to maintain blinding.
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
- •Age ≥ 18 years, including fertile women*
- •Blunt/Penetrating trauma patient
- •Direct transfer from the scene of the accident to Rigshospitalets Traume Center
- •Trauma team activation * There is no added risk for enrolment of fertile women as oxygen administration is approved for this group of patients.
排除标准
- •Patients in cardiac arrest before/at admission
- •Patients with a suspicion of smoke inhalation
- •No hospital admission after initial treatment in trauma center
研究组 & 干预措施
Liberal oxygen
Liberal oxygen administration (to mimic current practice) for the first 24 hours without interruption.
In the trauma bay and during intrahospital transportation this implies administration of a FiO2 of 1.0 for intubated patients and an oxygen flow on a non-rebreather with reservoir of 15 l/min for non-intubated patients. In the operating room, patients will receive a FiO2 of ≥ 0.8 to obtain a saturation of ≥ 98%. Patients admitted to the ICU/PACU/floor will receive and FiO2 of ≥ 0.8 or more to obtain a saturation of ≥ 98% when intubated and for non-intubated patients a non-rebreather with reservoir will be set to 15 l/min.
干预措施: Liberal Oxygen (Drug)
Titrated oxygen
Titrated oxygen administration for the first 24 hours without interruption. Lowest dosage of oxygen possible in order to achieve a saturation of at least 94%, either using mechanical ventilation (intubated patients), a nasal cannula, a non-rebreather or nothing.
A saturation above 94% shall not be aimed for using supplemental oxygen, and thus only patients without oxygen requirement shall have saturations above 94%.
The intervention will only be interrupted in case the saturation becomes unmeasurable - if this happens, the treating physician shall treat the patient as he/she judges best fit. As soon as the saturation is measurable again, the intervention will resume. The treating physician must document and explain the situation.
干预措施: Titrated Oxygen (Drug)
结局指标
主要结局
Composite Primary Outcomes
时间窗: 30 days
30-day mortality and major respiratory complications within 30 days (pneumonia (CDC criteria), acute respiratory distress syndrome (ARDS), acute lung injury (ALI)).
次要结局
- Glasgow Outcome Scale Extended (GOSE)(Assessed 30 days post-trauma (questionnaire through telephone follow-up if discharged))
- Pneumonia(30 days post-trauma (questionnaire through telephone follow-up))
- Intensive Care Unit length of stay(From date of randomization until the date of first documented discharge from the intensive care unit, up to 100 months)
- Hospital length of Stay(From date of randomization until the date of first documented discharge from the hospital, up to 100 months)
- Days on mechanical ventilation(From date of randomization until the date of first documented extubation, up to 100 months)
研究者
Josefine Stokholm Bækgaard
Medical Doctor (MD)
Rigshospitalet, Denmark