Agitation, Delirium, Intensive Care Unit Delirium
Conditions
Keywords
Acupuncture, Critically ill, Intensive care, Delirium, Agitation
Brief summary
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
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
Interventions
OTHERAcupuncture (Press Tack Needle)
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.
OTHERpress tack placebo
press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element.
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Our study goal is the measure the effectiveness of press tack needles (acupuncture group) in reducing delirium severity in critically ill patients in the ICU. In order to ensure a double bind procedure, we will implement the use of press tack placebos (control group) as a competitor. In addition to the mentioned above interventions, patients in both groups will receive routine ICU care as per individual patient's needs.
Intervention model description
two groups, randomized, pre-post intervention study
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensive Care Delirium Screening Checklist | 4 weeks | A common delirium examination in the intensive care unit lowest score:1 ,highest score:8 , a score of 4 or higher indicates delirium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mechanical ventilation in days | 4 weeks | mechanical ventilation day is at least 5 hours under ventilator |
| intensive care unit (ICU) stay in days | 4 weeks | number of days a patient stays in the intensive care unit |
| hospital stay in days | 4 weeks | number of days a patient stays in the hospital |
| intensive care unit (ICU) mortality | 4 weeks | the number of patients die in the intensive care unit (ICU) |
| Richmond Agitation-Sedation Scale | 4 weeks | 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 |
| drug use | 4 weeks | daily dose of: sedative drugs, muscle relaxant or atypical antipsychotics |
| Blood pressure | one hour before the interventions | patients systolic and diastolic blood pressure |
| heart rate | one hour before the interventions | patients heart rate |
| hospital mortality | 4 weeks | the number of patients die in the hospital |
Countries
Taiwan
Outcome results
None listed