Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 801
- 试验地点
- 1
- 主要终点
- Survival at Day 7
研究概览
简要总结
Patients who are having problems breathing sometimes require placement of a breathing tube in their mouth and windpipe. The purpose of this breathing tube is to save the patient's life. It is common to give the patient a medication to sedate him or her before the breathing tube is placed. For patients who are gravely ill two medications are commonly used: etomidate or ketamine. Both medications have risks and benefits. Researchers at UT-Southwestern Medical Center and Parkland Memorial Hospital would like to do a study to figure out which one is better for our patients.
详细描述
Critically ill individuals who require emergency endotracheal intubation (placement of a breathing tube in the patient's mouth) usually require sedation or anesthesia to make this process tolerable. There are several medication choices for anesthesia, including medications like etomidate, ketamine and propofol. Of these, etomidate and ketamine are frequently used for critically ill patients because they have minimal effects on the patient's vital signs (blood pressure and heart rate). Both etomidate and ketamine are standard-of-care medications, locally and nationally, and both are frequently used to sedate a patient for this procedure. Both etomidate and ketamine have potential side effects. One of the potential side effects of etomidate is suppression of adrenal gland function. It is not known if this affects patients' outcomes in significant ways. One of the potential side effects of ketamine is a slight increase in patients' heart rates. It is not known if this affects patients' outcomes in significant ways.
The EvK Trial will be conducted at Parkland Memorial Hospital by investigators in the Departments of Anesthesiology, Emergency Medicine, Medicine / Critical Care Medicine, Surgery, and Pharmacy. The study will randomize critically ill patients who require emergency endotracheal intubation to one of two groups: Etomidate or Ketamine. We will observe the patients' outcomes. The only study intervention involves randomizing individual patients to one medication or the other. All study follow-up beyond that point is done by review of medical records.
Because of the nature of this study - an emergency procedure on a critically ill patient - the study will require institutional review board permission not to obtain written informed consent from the patient prior to randomization of study drug for administration for endotracheal tube placement. Prior to enrollment of patients the study team will carry out a comprehensive Community Consultation Plan, which is designed to inform the community about the research study. This is in accordance with rules set forth by the U.S. Food and Drug Administration (FDA 21 CFR 50.24).
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
- 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
- •Adult patient (male or female) requiring emergency endotracheal intubation.
排除标准
- •Children (<18 years old).
- •Women who are known to be pregnant.
- •Any patient who has been previously randomized in the EvK Trial.
- •Patients who require endotracheal intubation without sedative medication. For example, patients in full cardiac arrest.
- •Patients with a known allergy to ketamine or etomidate.
- •Any individual wearing a MedAlert bracelet indicating that he/she has formally opted out of the EvK Trial.
研究组 & 干预措施
Etomidate
Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
干预措施: Etomidate (Drug)
Etomidate
Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
干预措施: Emergency Endotracheal Intubation (Procedure)
Etomidate
Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
干预措施: Mechanical Ventilation (Device)
Ketamine
Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.
干预措施: Ketamine (Drug)
Ketamine
Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.
干预措施: Emergency Endotracheal Intubation (Procedure)
Ketamine
Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.
干预措施: Mechanical Ventilation (Device)
结局指标
主要结局
Survival at Day 7
时间窗: Day 7
Survival is defined as the number of participants survived at day 7 following emergency endotracheal intubation
次要结局
- Duration of Mechanical Ventilation(From time of documented insertion until the time of documented removal, assessed up to 28 days)
- Duration of Catecholamine Therapy(From time of documented start of therapy until the time of documented end of therapy, assessed up to 28 days)
- Survival at Day 28(Day 28)
- Sequential Organ Failure Assessment (SOFA) Scores(Day 1, Day 2, Day 3, Day 4)
- Length of Stay in ICU(Assessed up to 28 days)
- Number of Participants With New Diagnosis of Adrenal Insufficiency(Day 28)
- Number of Attempts Necessary to Intubate(Immediate (Day 1))
研究者
Gerald Matchett
Associate Professor of Medicine
University of Texas Southwestern Medical Center