Intravenous Epinephrine Bolus for Prevention of Postintubation Collapse in Intensive Care Septic Patients Predicted by Shock Index.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- incidence of cardiac arrest during intubation
研究概览
简要总结
Endotracheal intubation is a lifesaving procedure that is performed in various settings within the hospital or even in the pre-hospital field. However, it can result in serious hemodynamic complications, such as post-intubation hypotension (PIH) and cardiac arrest. Push-dose pressor (PDP) is common practice for rapid hemodynamic correction in post-intubation hypotension. In this study the investigators will use intravenous Epinephrine bolus for prevention of post intubation collapse in septic patients predicted by shock index in intensive care unit.
详细描述
- Type of Study: Randomized prospective comparative study.
- Study Setting: Ain Shams University Hospitals at Intensive care units department. • Study Period: 4 months.
- Study Population: -Inclusion Criteria: septic patients of either sex above 18 years of age, will need emergent intubation during ICU admission, shock index (SI) > 0.9.
Exclusion Criteria: patient's family refusal, age <18, pregnant, Patients with tachyarrhythmias, traumatic patients, patient with shock index <0.9, ischemic heart patients, any comorbidities contraindicated to take epinephrine and allergic to epinephrine will be excluded from the study. • Sampling Method: Study will include (44) patients who fulfill all the points in the inclusion criteria will be randomized into 2 equal groups, each consisting of (22) patients, namely group (E) and group (F). • Sample Size: 44 patients.
• Ethical Considerations: Approval of the Ethical Committee and written informed consent from all participants' legal guardians will be obtained after explanation. • Study Procedures: Push-dose epinephrine will be prepared (following mixing instructions) and administered via large bore (14-18 gauge) peripheral intravenous (IV) access.
(44) Patients will randomly be assigned into two groups, (E group for epinephrine n= 22, F group for IV bolus isotonic fluid n=22). Randomization will be done using sequentially numbered, opaque, sealed envelopes containing computer generated random allocations.
In Group (E) patients will receive epinephrine prepared as 10 ml syringe filled with 10 ml of epinephrine 10 mcg/ml. prepared by drawing 1ml epinephrine 1mg ampule into 9 ml saline then discarding 9 ml and adding another 9 ml saline. now the investigators have 10 ml of epinephrine 10 mcg/ ml (1:100,000), then 10 µg will be given intravenously every 2-minute starting before intubation and continue during and after intubation for 4 times or until the systolic blood pressure (SBP) will be at least 90 mmHg or the mean arterial pressure (MAP) 65 mmHg or greater or after 4th dose of epinephrine and still hypotensive vasopressor (norepinephrine 30 ng /kg/min.) will be added or increased. In Group (F) patients will receive IV bolus isotonic fluid 500 ml as it is yet the standard method used before intubation.
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
- 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
- •septic patients of either sex above 18 years of age, will need emergent intubation during ICU admission, shock index (SI) > 0.9.
排除标准
- •patient's family refusal, age <18, pregnant, Patients with tachyarrhythmias, traumatic patients, patient with shock index <0.9, ischemic heart patients, any comorbidities contraindicated to take epinephrine and allergic to epinephrine will be excluded from the study.
研究组 & 干预措施
E group for epinephrine
In Group (E) patients will receive epinephrine prepared as 10 ml syringe filled with 10 ml of epinephrine 10 mcg/ml. prepared by drawing 1ml epinephrine 1mg ampule into 9 ml saline then discarding 9 ml and adding another 9 ml saline. now the investigators have 10 ml of epinephrine 10 mcg/ ml (1:100,000), then 10 µg will be given intravenously every 2-minute starting before intubation and continue during and after intubation for 4 times or until the systolic blood pressure (SBP) will be at least 90 mmHg or the mean arterial pressure (MAP) 65 mmHg or greater or after 4th dose of epinephrine and still hypotensive vasopressor (norepinephrine 30 ng /kg/min.) will be added or increased.
干预措施: epinephrine (Drug)
Group (F)
In Group (F) patients will receive IV bolus isotonic fluid 500 ml as it is yet the standard method used before intubation
干预措施: isotonic fluid (Drug)
结局指标
主要结局
incidence of cardiac arrest during intubation
时间窗: during and till 30 minutes after intubation
cardiac arrest
sever hypotension
时间窗: during and till 30 minutes after intubation
decrease \> 20% of baseline mean arterial blood pressure
次要结局
- need for or increase dose of postintubation vasopressor(during and till 30 minutes after intubation)
- incidence of arrythmias(during and till 30 minutes after intubation)
- bradycardia(during and till 30 minutes after intubation)
- increased lactate(lactate will be measured 1 hour after intubation)
- decreased oxygen saturation(during and till 30 minutes after intubation)