The Effectiveness of Acupuncture for Complications in Critically Ill Patients: Multiple Centers a Double-Blind Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- arrhythmia
研究概览
简要总结
Introduction:
Intensive care unit (ICU) is a special department in the health care facility. Although with high development of modern medicine nowadays, the average mortality rate in ICU is still around 7 to 20 %. There are a few tricky problems that intensivists and ICU nurses faced very often, including ICU delirium, arrhythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients.
Methods: A randomized control trial will examine the effect of press tack acupuncture vs. press tack placebos. The patients will be randomly divided (1:1) into one of two groups. A total of 80 ICU patients will have to meet the following criteria: age 20-90, newly ICU admission(<48 hours), APACHE score <30, one or no inotropic medicine use, FiO2< 60%. Three interventions will be given in each group. The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain. We will also record ICU mortality, ICU stays and hospital days.
详细描述
Introduction
Intensive care unit (ICU) is a special department in the health care facility. Although with high development of modern medicine nowadays, the average mortality rate in ICU is still around 7 to 20 %. There are a few tricky problems that intensivists and ICU nurses faced very often, including ICU delirium, arrhythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients.
Methods: A randomized control trial will examine the effect of press tack acupuncture vs. press tack placebos. The patients will be randomly divided (1:1) into one of two groups. A total of 80 ICU patients will have to meet the following criteria: age 20-90, newly ICU admission(<48 hours), APACHE score <30, one or no inotropic medicine use, FiO2< 60%. Three interventions will be given in each group. The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain. We will also record ICU mortality, ICU stays and hospital days.
Expected outcome: The study finding will help to determine the therapeutic effect of acupuncture for ICU complications.
Other information: This study will be conducted in the ICU departments of China medical hospital and Asia University Hospital, Taichung city, Taiwan. The study is conducted on stable ICU patients and we don't anticipate any serious risk for adverse events following the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20--90
- •newly ICU admission (<48 hours)
- •APACHE score <30
- •Less than 3 inotropic medicine use
- •Fi02< 60%.
排除标准
- •• Coagulopathy: Prolong Prothrombin Time (PPT) activated Partial Thromboplastin Time (aPTT) more than 4 times
- •Thrombocytopenia - low platelet count
- •Clinically unstable: receiving two or more inotropic agents or Fraction of Inspired Oxygen (Fi02) >60%
- •Primary central nervous system disorder: stroke, traumatic brain injury, central nervous system infections, brain tumors, recent intracranial surgery
- •Already under other traditional medicine intervention during hospitalization
- •Skin damage of more than 20% of the body skin.
研究组 & 干预措施
Acupuncture with press tack needle group (Acu)
Patients in acupuncture group will receive traditional Chinese acupuncture using Press Tack Needle (PYONEX 0.20 x l.5mm made by Seirin Corporation). The following acupoints will be used: HT 7 (Shen Men), PC 6 (Nei Guan), LU 9 (Tai yuan), LI 4 (He Gu), SP 3 (Tai Bai,) ST 44 (Nei ting), LIV 3 (Tai Chong). The treatment will use bilateral acupuncture Interventions will be given on day 1, 3, and 5 after patient's enrolment.
干预措施: pess tack acupuncture (Other)
Placebo group press tack placebo (Con)
Patients randomized to the control group will receive a press lack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element. The point selection will be identical to the acupuncture group: HT 7 (Shen Men), PC 6 (Nei Guan), LU 9 (Tai yuan), L1 4 (He Gu), SP 3; (Tat Bai), ST 44 (Ne1 tmg), LIV 3 (Tat Chong). Interventions will be given on days 1, 3, and 5 after the patient's enrolment.
干预措施: pess tack placebo (Other)
结局指标
主要结局
arrhythmia
时间窗: at the patient's ICU discharge, on average 1 week
incidence of arrhythmia
delirium
时间窗: at the patient's ICU discharge, on average 1 week
4 or more points according to the Intensive Care Delirium Screening Checklist (ICDSC)(0-8 scale, score of less than 4 points indicate no delirium, 4 or more indicate delirium) and a Richmond Agitation-Sedation Scale (RASS) score of: +l, +2, +3, +4 - 1, -2 (score meanings +1 - 4 = levels of agitation, -1-4= levels of sudation, 0 = normal mental state.
feeding intolorance
时间窗: at the patient's ICU discharge, on average 1 week
measured by days to reach the target Energy Fxpenditure
pain in the intensive care unit (ICU)
时间窗: at the patient's ICU discharge, on average 1 week
For pain the Numeric Rating scale will be applied in patients that are able to express their self. As well as the Behavioral pain scale. The Critical Care Pain Observation Tool (CPOT) 0-8, will also be filled by the doctor and nurses along with the dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications.
dose of arrhythmia drugs
时间窗: at the patient's ICU discharge, on average 1 week
the dose of Adenosine, calcium channel blockers, or beta-blocking agents or other arrhythmia drugs .
dose of use of prokinetic drugs
时间窗: at the patient's ICU discharge, on average 1 week
does of metoclopramide, Erythromycin or other prokinetic drugs
analgesic medication use
时间窗: at the patient's ICU discharge, on average 1 week
dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications.
delirium drug use
时间窗: at the patient's ICU discharge, on average 1 week
addition to drug use (a daily dose of sedative drugs, muscle relaxant, or atypical antipsychotics IV Haloperidol Benzodiazepines, Precedex, Propofol and oral Quediapine)
次要结局
- ventilator data(day 1,3,5,7)
- diarrhea(at the patient's ICU discharge, on average 1 week)
- the use of Parental nutrition(at the patient's ICU discharge, on average 1 week)
- the need for a post-pyloric tube(at the patient's ICU discharge, on average 1 week)
- vomitus(at the patient's ICU discharge, on average 1 week)
- Intravenous (IV) injected albumin(at the patient's ICU discharge, on average 1 week)
- heart rate(day 1,3,5,7)
- blood pressure(day 1,3,5,7)
- SpO2 oxygen saturation(day 1,3,5,7)
- Respiratory rate(day 1,3,5,7)
- mean arterial pressure(day 1,3,5,7)
- Body temperature(at the patient's ICU discharge, on average 1 week)
- constipation days(at the patient's ICU discharge, on average 1 week)
- gastrointestinal (GI) bleeding(at the patient's ICU discharge, on average 1 week)
- albumin blood levels(at the patient's ICU discharge, on average 1 week)
- Overall Satisfaction of patient family(at the patient Hospital discharge, on average 1 month)
- mechanical ventilation days days(at the patient Hospital discharge, on average 1 month)
- ICU stay(at the patient's ICU discharge, on average 1 week)
- acupuncturist blinding(after intervention on day 5)
- hospital days(at the patient Hospital discharge, on average 1 month)
- ICU mortality(at the patient's ICU discharge, on average 1 week)
- Hospital mortality(at the patient Hospital discharge, on average 1 month)
- cost of hospital admission(at the patient Hospital discharge, on average 1 month)
- cost of ICU admission(at the patient's ICU discharge, on average 1 week)
研究者
Yu-Chen Lee
Principal Investigator
China Medical University Hospital