The Effectiveness of Acupuncture for Complications in Critically Ill Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness of Acupuncture for Complications in Critically Ill Patients: Multiple Centers a Double-Blind Randomized Control Trial

Conditions
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Delirium, Agitation, Arrhythmia, Feeding Intolerance, Pain, Acute

Intervention / Treatment
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* Other: pess tack acupuncture
* Other: pess tack placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20--90 newly ICU admission (<48 hours) APACHE score <30 Less than 3 inotropic medicine use Fi02< 60%. Exclusion Criteria: • 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicenter parallel arm double-blind randomized control trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture with press tack needle group (Acu)<br>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. | Other: pess tack acupuncture<br>* 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.<br>* Other names: Press Tack Needle/ sticker needle/ PYONEX;|
| Placebo Comparator: Placebo group press tack placebo (Con)<br>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. | Other: pess tack placebo<br>* pess tack stickers without a needle<br>* Other names: PYONEX placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arrhythmia | incidence of arrhythmia | 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. | at the patient's ICU discharge, on average 1 week | 
| feeding intolorance | measured by days to reach the target Energy Fxpenditure | 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. | 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 . | at the patient's ICU discharge, on average 1 week | 
| dose of use of prokinetic drugs | does of metoclopramide, Erythromycin or other prokinetic drugs | 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. | 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) | at the patient's ICU discharge, on average 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | at the patient's ICU discharge, on average 1 week | 
| vomitus | in microliters | at the patient's ICU discharge, on average 1 week | 
| diarrhea | in microliters | at the patient's ICU discharge, on average 1 week | 
| constipation days | 3 days without stool discharge | at the patient's ICU discharge, on average 1 week | 
| gastrointestinal (GI) bleeding | in number of times | at the patient's ICU discharge, on average 1 week | 
| albumin blood levels | serum albumin blood levels | at the patient's ICU discharge, on average 1 week | 
| Intravenous (IV) injected albumin | IV injected albumin in grams | at the patient's ICU discharge, on average 1 week | 
| heart rate | number of beats per minute | day 1,3,5,7 | 
| blood pressure | systolic and diastolic blood pressure in mm Hg | day 1,3,5,7 | 
| SpO2 oxygen saturation | Sp02 oxygen saturation levels | day 1,3,5,7 | 
| Respiratory rate | measured by number of breath in one minute | day 1,3,5,7 | 
| mean arterial pressure | average pressure in a patient's arteries during one cardiac cycle | day 1,3,5,7 | 
| Body temperature | number of days of body temperature over 38 °C | at the patient's ICU discharge, on average 1 week | 
| ventilator data | ventilator data | 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). | at the patient Hospital discharge, on average 1 month | 
| mechanical ventilation days days | number of days under mechanical ventilation | at the patient Hospital discharge, on average 1 month | 
| ICU stay | number of admission days to the ICU | at the patient's ICU discharge, on average 1 week | 
| hospital days | number of admission days to the hospital | at the patient Hospital discharge, on average 1 month | 
| ICU mortality | number of patients died in the ICU | at the patient's ICU discharge, on average 1 week | 
| Hospital mortality | number of patients died in the hospital | at the patient Hospital discharge, on average 1 month | 
| cost of hospital admission | cost of hospital admission in New Taiwan Dollars {TWD) | at the patient Hospital discharge, on average 1 month | 
| cost of ICU admission | cost of ICU admission in New Taiwan Dollars {TWD). | 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 | after intervention on day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, intensive care, delirium, agitation, double blinded randomized control study