The Effectiveness of Acupuncture for Delirium in Critically Ill Patients

Not Applicable

• Conditions: Agitation; Delirium; Intensive Care Unit Delirium

• Registration Number: NCT04312893
• Lead Sponsor: China Medical University Hospital

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

Study Timeline

• Study Start: 2020-03-12
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

medical and surgical intensive care department, medical and the surgical ward of China Medical University Hospital; 🇨🇳 Taichung, Taiwan