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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
80
Patients enrolled will receive intervention in a form of either press tack acupuncture needles or press tack placebos. Three total intervention sessions will be taken place on day 1,3,5 from patient's enrolment. Needles/placebos skin withdrawal will be done 48 hours after treatment by an acupuncture doctor or by a trained ICU nurne. In cases when a patient will be transferred from the ICU, the 3 study interventions will be continued in the new ward.
pess tack stickers without a needle
arrhythmia
incidence of arrhythmia
Time frame: at the patient's ICU discharge, on average 1 week
delirium
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.
Time frame: at the patient's ICU discharge, on average 1 week
feeding intolorance
measured by days to reach the target Energy Fxpenditure
Time frame: at the patient's ICU discharge, on average 1 week
pain in the intensive care unit (ICU)
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.
Time frame: at the patient's ICU discharge, on average 1 week
dose of arrhythmia drugs
the dose of Adenosine, calcium channel blockers, or beta-blocking agents or other arrhythmia drugs .
Time frame: at the patient's ICU discharge, on average 1 week
dose of use of prokinetic drugs
does of metoclopramide, Erythromycin or other prokinetic drugs
Time frame: at the patient's ICU discharge, on average 1 week
analgesic medication use
dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications.
Time frame: at the patient's ICU discharge, on average 1 week
delirium drug use
addition to drug use (a daily dose of sedative drugs, muscle relaxant, or atypical antipsychotics IV Haloperidol Benzodiazepines, Precedex, Propofol and oral Quediapine)
Time frame: at the patient's ICU discharge, on average 1 week
the use of Parental nutrition
patients who cannot digest with daily NG tube: drainage: more than 500ml per day or severe diarrhea more the 1000 ml per day
Time frame: at the patient's ICU discharge, on average 1 week
the need for a post-pyloric tube
patients who cannot digest with daily NG tube and by doctor decision
Time frame: at the patient's ICU discharge, on average 1 week
vomitus
in microliters
Time frame: at the patient's ICU discharge, on average 1 week
diarrhea
in microliters
Time frame: at the patient's ICU discharge, on average 1 week
constipation days
3 days without stool discharge
Time frame: at the patient's ICU discharge, on average 1 week
gastrointestinal (GI) bleeding
in number of times
Time frame: at the patient's ICU discharge, on average 1 week
albumin blood levels
serum albumin blood levels
Time frame: at the patient's ICU discharge, on average 1 week
Intravenous (IV) injected albumin
IV injected albumin in grams
Time frame: at the patient's ICU discharge, on average 1 week
heart rate
number of beats per minute
Time frame: day 1,3,5,7
blood pressure
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systolic and diastolic blood pressure in mm Hg
Time frame: day 1,3,5,7
SpO2 oxygen saturation
Sp02 oxygen saturation levels
Time frame: day 1,3,5,7
Respiratory rate
measured by number of breath in one minute
Time frame: day 1,3,5,7
mean arterial pressure
average pressure in a patient's arteries during one cardiac cycle
Time frame: day 1,3,5,7
Body temperature
number of days of body temperature over 38 °C
Time frame: at the patient's ICU discharge, on average 1 week
ventilator data
ventilator data
Time frame: day 1,3,5,7
Overall Satisfaction of patient family
Overall Satisfaction of patient family will be measured by the European Family Satisfaction with Care in the Intensive Care Unit (EURO FS-ICU).
Time frame: at the patient Hospital discharge, on average 1 month
mechanical ventilation days days
number of days under mechanical ventilation
Time frame: at the patient Hospital discharge, on average 1 month
ICU stay
number of admission days to the ICU
Time frame: at the patient's ICU discharge, on average 1 week
hospital days
number of admission days to the hospital
Time frame: at the patient Hospital discharge, on average 1 month
ICU mortality
number of patients died in the ICU
Time frame: at the patient's ICU discharge, on average 1 week
Hospital mortality
number of patients died in the hospital
Time frame: at the patient Hospital discharge, on average 1 month
cost of hospital admission
cost of hospital admission in New Taiwan Dollars {TWD)
Time frame: at the patient Hospital discharge, on average 1 month
cost of ICU admission
cost of ICU admission in New Taiwan Dollars {TWD).
Time frame: at the patient's ICU discharge, on average 1 week
acupuncturist blinding
blinding questioner will ask the acupuncturist to which group he/she guessed he/she applied the intervention
Time frame: after intervention on day 5