Clinical trial NCT04312893: The Effectiveness of Acupuncture for Delirium in Critically Ill Patients
Official title: The Effectiveness of Acupuncture for Delirium in Critically Ill Patients: a Double Blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intensive Care Unit Delirium
Delirium
Agitation
Keywords: Acupuncture
Critically ill
Intensive care
Delirium
Agitation
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups, randomized, pre-post intervention study
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Intensive Care Delirium Screening Checklist
timeFrame: 4 weeks
Secondary outcomes:
measure: Richmond Agitation-Sedation Scale
timeFrame: 4 weeks
measure: mechanical ventilation in days
timeFrame: 4 weeks
measure: intensive care unit (ICU) stay in days
timeFrame: 4 weeks
measure: hospital stay in days
timeFrame: 4 weeks
measure: intensive care unit (ICU) mortality
timeFrame: 4 weeks
measure: hospital mortality
timeFrame: 4 weeks
measure: drug use
timeFrame: 4 weeks
measure: Blood pressure
timeFrame: one hour before the interventions
measure: heart rate
timeFrame: one hour before the interventions
measure: Blood pressure
timeFrame: one hour after the interventions
measure: heart rate
timeFrame: one hour after the interventions
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: medical and surgical intensive care department, medical and the surgical ward of China Medical University Hospital
Study officials:
References: