Delirium Clinical Trial
Official title:
The Effectiveness of Acupuncture for Delirium in Critically Ill Patients: a Double Blind Randomized Control Trial
Verified date | August 2021 |
Source | China Medical University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | May 30, 2022 |
Est. primary completion date | May 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | medical and surgical intensive care department, medical and the surgical ward of China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | mechanical ventilation in days | mechanical ventilation day is at least 5 hours under ventilator | 4 weeks | |
Secondary | intensive care unit (ICU) stay in days | number of days a patient stays in the intensive care unit | 4 weeks | |
Secondary | hospital stay in days | number of days a patient stays in the hospital | 4 weeks | |
Secondary | intensive care unit (ICU) mortality | the number of patients die in the intensive care unit (ICU) | 4 weeks | |
Secondary | hospital mortality | the number of patients die in the hospital | 4 weeks | |
Secondary | drug use | daily dose of: sedative drugs, muscle relaxant or atypical antipsychotics | 4 weeks | |
Secondary | Blood pressure | patients systolic and diastolic blood pressure | one hour before the interventions | |
Secondary | heart rate | patients heart rate | one hour before the interventions | |
Secondary | Blood pressure | patients systolic and diastolic blood pressure | one hour after the interventions | |
Secondary | heart rate | patients heart rate | one hour after the interventions |
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