The Effectiveness of Acupuncture for Delirium in Critically Ill Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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The Effectiveness of Acupuncture for Delirium in Critically Ill Patients: a Double Blind Randomized Control Trial

Conditions
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Intensive Care Unit Delirium, Delirium, Agitation

Intervention / Treatment
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* Other: Acupuncture (Press Tack Needle)
* Other: press tack placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-90 Apache score <30 Patients admitted in the ICU Positive delirium score as: 4 or more points according to the Intensive Care Delirium Screening Checklist (ICDSC) Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4 -1, -2 Exclusion Criteria: Coagulopathy: Prolong Prothrombin Time (PPT) activated Partial Thromboplastin Time (aPTT) more than 4 times Thrombocytopenia - low platelet count Clinically unstable: receiving two inotropic agents or Fraction of Inspired Oxygen (FiO2) >70% Rass score: 0, -3, -4 (at the time of enrollment) Primary central nervous system disorder: stroke, traumatic brain injury, central nervous system infections, brain tumors, recent intracranial surgery Alcohol or substance withdrawal.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two groups, randomized, pre-post intervention study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group (ACU)<br>Patients in acupuncture group will receive traditional Chinese acupuncture combined with Tung's style acupuncture using Press Tack Needle (PYONEX Φ0.20×0.6 mm 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. The following acupoints will be used: HT 7 (Shen Men), PC 6 (Nei Guan), Yin Tang (EX-HN 3), San Shang (55-02) (three point from Dong's acupuncture system) and the auricular Shen Men point. The treatment will use bilateral acupuncture (if patient's condition does not allow it, unilateral acupuncture will be done). The patient will lie in a supine position during the treatment. Acupuncturist will disinfect the acupoint location with an alcohol pad (70% alcohol), then the acupuncturist will press the needles sticker to the mentioned above acupoints. Interventions will be given on day 1, 3, and 5 after patient's enrolment. | Other: Acupuncture (Press Tack Needle)<br>* 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.<br>* Other names: Press Tack Needle/ sticker needle/PYONEX;|
| Placebo Comparator: Control group (CON)<br>Patients randomized to the control group will receive press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element. The point selection will be identical to acupuncture group: HT 7 (Shen Men), PC 6 (Nei Guan), Yin Tang (EX-HN 3), San Shang (55-02) (three point from Dong's acupuncture system) and the auricular Shen Men point. The treatment methods and patients position will be identical to acupuncture group. Interventions will be given on day 1, 3, and 5 after patient's enrolment. | Other: press tack placebo<br>* press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element.<br>* Other names: PYONEX placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive 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 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks | 
| mechanical ventilation in days | mechanical ventilation day is at least 5 hours under ventilator | 4 weeks | 
| intensive care unit (ICU) stay in days | number of days a patient stays in the intensive care unit | 4 weeks | 
| hospital stay in days | number of days a patient stays in the hospital | 4 weeks | 
| intensive care unit (ICU) mortality | the number of patients die in the intensive care unit (ICU) | 4 weeks | 
| hospital mortality | the number of patients die in the hospital | 4 weeks | 
| drug use | daily dose of: sedative drugs, muscle relaxant or atypical antipsychotics | 4 weeks | 
| Blood pressure | patients systolic and diastolic blood pressure | one hour before the interventions | 
| heart rate | patients heart rate | one hour before the interventions | 
| Blood pressure | patients systolic and diastolic blood pressure | one hour after the interventions | 
| heart rate | patients heart rate | one hour after the interventions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Critically ill, Intensive care, Delirium, Agitation