Comparaison of 2 SpO2 Level Measured by Pulse Oxymetry in Complications of Acute Coronary Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- The frequency of significant desaturations (SpO2 <90% for at least 30 seconds)
研究概览
简要总结
During acute coronary syndrome, the American College of Cardiology and the American Heart Association recommend oxygen delivery to patients with less than 90% oxygen saturation. Oxygen therapy in these patients for a duration of at least 6 hours, but also stipulates that it is reasonable to administer oxygen to all acute coronary syndrome patients during the first six hours following the presentation. Hyperoxia also has well-established risks.
Our research hypotheses are:
(I) that current practices tend to use high oxygen flows resulting in high SpO2 levels during acute coronary syndrome.
(II) there is a high rate of desaturation in patients with acute coronary syndrome and an automatic adaptation of oxygen flows may reduce this frequency.
(III) that excessive oxygenation targets have no advantage. Our hypothesis is that maintaining a SpO2 of 90 to 94% is at least equivalent when compared to higher saturation objectives (SpO2 of 94 to 100%) with regard to the occurrence of complications in the patient in acute coronary syndrome . We will use two SpO2 targets with the FreeO2 system, 92 and 97%.
详细描述
Hypoxemia is a common problem encountered during acute coronary syndrome. During acute coronary syndrome, the American College of Cardiology and the American Heart Association recommend oxygen delivery to patients with less than 90% oxygen saturation. Oxygen therapy in these patients for a duration of at least 6 hours , but also stipulates that it is reasonable to administer oxygen to all acute coronary syndrome patients during the first six hours Following the presentation. However, the studies underlying these guidelines are few and far between, most of them having been done more than forty years ago.
Hyperoxia also has well-established risks.
Our research hypotheses are:
(I) that current practices tend to use high oxygen flows resulting in high SpO2 levels during acute coronary syndrome.
(II) there is a high rate of desaturation in patients with acute coronary syndrome and an automatic adaptation of oxygen flows may reduce this frequency. This will be our primary endpoint and will be tested with the use of the automated oxygen delivery system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients should have a proven diagnosis of acute high risk coronary syndrome as defined by the American Heart Association:
- •myocardial infarction with or without ST segment elevation: Ischemic changes in the electrocardiogram and positive cardiac biomarkers.
- •or Unstable angina: Typical or atypical cardiac symptoms, Ischemic electrocardiographic changes, Normal cardiac biomarkers.
排除标准
- •inclusion in another study refusing co-enrollment
- •chronic obstructive pulmonary disease with CO2 retention
- •sleep apnea-hypopnea syndrome with CPAP
- •traumatic brain injury
- •pregnancy
- •Age <18 years
- •Mechanical invasive or non-invasive ventilation
- •patient needing more than 5 lpm of oxygen to have SpO2 > 95%
研究组 & 干预措施
Control group
In this group, the nursing staff administed oxygen supply if necessary with the usual pratice in care unit for 24 hours after myocard infarction. In this group the SpO2 was recorded any time with FreeO2 device - recording mode.
干预措施: Automated oxygen administration (Device)
FreeO2 with SpO2 target = 92%
In this group oxygen flow was automatically adjusted with the FreeO2 device (automatic titration of oxygen flow) to achived SpO2 target set by clinicial for 24 hours after myocard infarction. In this group, the SpO2 target was set at 92%.
干预措施: Automated oxygen administration (Device)
FreeO2 with SpO2 target =97%
In this group oxygen flow was automatically adjusted with the FreeO2 device (automatic titration of oxygen flow) to achived SpO2 target set by clinicial for 24 hours after myocard infarction. In this group, the SpO2 target was set at 97%.
干预措施: Automated oxygen administration (Device)
结局指标
主要结局
The frequency of significant desaturations (SpO2 <90% for at least 30 seconds)
时间窗: 24 hours
次要结局
- Significant rhythm disorders, ischemic events(24 hours)
- The percentage of time spent in the target SpO2 area in the second and third groups, defined as SpO2 +/- 2% of the targeted SpO2 (range 90-94% for group 92% and range 95-99% for group 97%)(24 hours)
研究者
François Lellouche
Principal investigator
Laval University