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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04312893
Other study ID # CMUH109-REC3-006
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 12, 2020
Est. completion date May 30, 2022

Study information

Verified date August 2021
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

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.

Study Design


Intervention

Other:
Acupuncture (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.
press tack placebo
press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element.

Locations

Country Name City State
Taiwan medical and surgical intensive care department, medical and the surgical ward of China Medical University Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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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