Introduction: Intensive care unit (ICU) delirium is an acute onset of brain dysfunction, which can affect 25-80% of ICU patients. Delirium is also associated with long term cognition impairment, higher mortality and higher ICU costs. Previous acupuncture studies showed the potential to prevent delirium. This study will examine the ability of acupuncture to treat ICU delirium. Methods: A double-blind 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 patient will have to meet the following criteria: age 20-90, APACHE score \<30, Intensive Care Delirium Screening Checklist (ICDSC) \>4 points (indicates existing delirium), Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4, -1, -2. Three interventions will be given in each group. The main outcomes will be the delirium days according to the ICDSC.
Introduction: Intensive care unit (ICU) delirium is an acute onset of brain dysfunction, which can affect 25-80% of ICU patients. Delirium is also associated with long term cognition impairment, higher mortality and higher ICU costs. Previous acupuncture studies showed the potential to prevent delirium. This study will examine the ability of acupuncture to treat ICU delirium. Methods: A double-blind 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 patient will have to meet the following criteria: age 20-90, APACHE score \<30, Intensive Care Delirium Screening Checklist (ICDSC) \>4 points (indicates existing delirium), Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4, -1, -2. Three interventions will be given in each group. The main outcomes will be the delirium days according to the ICDSC. Expected outcome: The study finding will help to determine the therapeutic effect of acupuncture for critically ill delirium patients. Furthermore, the study design will involve longer needle/placebos retention which is less investigated nowadays. Other information: This study will be conducted in the ICU departments of China medical 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. The study will take place until May 2022. Keywords: acupuncture, critically ill, intensive care, delirium, agitation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Press Tack Needle (PYONEX made by Seirin Corporation). The needles appear identical to the press tack placebo with the only different is the needle itself which was removed in the placebo needles.
press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element.
medical and surgical intensive care department, medical and the surgical ward of China Medical University Hospital
Taichung, Taiwan
RECRUITINGIntensive Care Delirium Screening Checklist
A common delirium examination in the intensive care unit lowest score:1 ,highest score:8 , a score of 4 or higher indicates delirium
Time frame: 4 weeks
Richmond Agitation-Sedation Scale
A common scale to measure the severity on the delirium. The scale rates +4 to -4 Combative+4 Very agitated+3 Agitated+2 Restless+1 Alert and calm -0 Drowsy-1 Light sedation-2 Moderate sedation-3 Deep sedation-4
Time frame: 4 weeks
mechanical ventilation in days
mechanical ventilation day is at least 5 hours under ventilator
Time frame: 4 weeks
intensive care unit (ICU) stay in days
number of days a patient stays in the intensive care unit
Time frame: 4 weeks
hospital stay in days
number of days a patient stays in the hospital
Time frame: 4 weeks
intensive care unit (ICU) mortality
the number of patients die in the intensive care unit (ICU)
Time frame: 4 weeks
hospital mortality
the number of patients die in the hospital
Time frame: 4 weeks
drug use
daily dose of: sedative drugs, muscle relaxant or atypical antipsychotics
Time frame: 4 weeks
Blood pressure
patients systolic and diastolic blood pressure
Time frame: one hour before the interventions
heart rate
patients heart rate
Time frame: one hour before the interventions
Blood pressure
patients systolic and diastolic blood pressure
Time frame: one hour after the interventions
heart rate
patients heart rate
Time frame: one hour after the interventions
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