The Effectiveness of Acupuncture for Complications in Critically Ill Patients
- Conditions
- ArrhythmiaFeeding IntoleranceAgitationDeliriumPain, Acute
- Interventions
- Other: pess tack acupunctureOther: pess tack placebo
- Registration Number
- NCT04950738
- Lead Sponsor
- China Medical University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
-
Age 20--90
- newly ICU admission (<48 hours)
- APACHE score <30
- Less than 3 inotropic medicine use
- Fi02< 60%.
-
• 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acupuncture with press tack needle group (Acu) pess tack acupuncture 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. Placebo group press tack placebo (Con) pess tack placebo 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.
- Primary Outcome Measures
Name Time Method arrhythmia at the patient's ICU discharge, on average 1 week incidence of arrhythmia
delirium 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 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) 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 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 at the patient's ICU discharge, on average 1 week does of metoclopramide, Erythromycin or other prokinetic drugs
analgesic medication use 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 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)
- Secondary Outcome Measures
Name Time Method diarrhea at the patient's ICU discharge, on average 1 week in microliters
the use of Parental nutrition at the patient's ICU discharge, on average 1 week patients who cannot digest with daily NG tube: drainage: more than 500ml per day or severe diarrhea more the 1000 ml per day
the need for a post-pyloric tube at the patient's ICU discharge, on average 1 week patients who cannot digest with daily NG tube and by doctor decision
vomitus at the patient's ICU discharge, on average 1 week in microliters
Intravenous (IV) injected albumin at the patient's ICU discharge, on average 1 week IV injected albumin in grams
heart rate day 1,3,5,7 number of beats per minute
blood pressure day 1,3,5,7 systolic and diastolic blood pressure in mm Hg
SpO2 oxygen saturation day 1,3,5,7 Sp02 oxygen saturation levels
Respiratory rate day 1,3,5,7 measured by number of breath in one minute
mean arterial pressure day 1,3,5,7 average pressure in a patient's arteries during one cardiac cycle
Body temperature at the patient's ICU discharge, on average 1 week number of days of body temperature over 38 °C
constipation days at the patient's ICU discharge, on average 1 week 3 days without stool discharge
gastrointestinal (GI) bleeding at the patient's ICU discharge, on average 1 week in number of times
albumin blood levels at the patient's ICU discharge, on average 1 week serum albumin blood levels
ventilator data day 1,3,5,7 ventilator data
Overall Satisfaction of patient family at the patient Hospital discharge, on average 1 month Overall Satisfaction of patient family will be measured by the European Family Satisfaction with Care in the Intensive Care Unit (EURO FS-ICU).
mechanical ventilation days days at the patient Hospital discharge, on average 1 month number of days under mechanical ventilation
ICU stay at the patient's ICU discharge, on average 1 week number of admission days to the ICU
hospital days at the patient Hospital discharge, on average 1 month number of admission days to the hospital
ICU mortality at the patient's ICU discharge, on average 1 week number of patients died in the ICU
Hospital mortality at the patient Hospital discharge, on average 1 month number of patients died in the hospital
cost of hospital admission at the patient Hospital discharge, on average 1 month cost of hospital admission in New Taiwan Dollars {TWD)
cost of ICU admission at the patient's ICU discharge, on average 1 week cost of ICU admission in New Taiwan Dollars {TWD).
acupuncturist blinding after intervention on day 5 blinding questioner will ask the acupuncturist to which group he/she guessed he/she applied the intervention