The Effectiveness of Acupuncture for Delirium in Critically Ill Patients

The Effectiveness of Acupuncture for Delirium in Critically Ill Patients: a Double Blind Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium; Agitation; Intensive Care Unit Delirium
• Intervention / Treatment: Other: Acupuncture (Press Tack Needle); Other: press tack placebo

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404472
    • Recruiting
    • medical and surgical intensive care department, medical and the surgical ward of China Medical University Hospital
    • Contact: Peiyu Kao, M.D.; Phone Number: +886910698942; Email: ludouto@gmail.com
    • Contact: Eyal Ben-Arie, M.S.; Phone Number: +886989172041; Email: benarie19@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group (ACU); Patients in acupuncture group will receive traditional Chinese acupuncture combined with Tung's style acupuncture using Press Tack Needle (PYONEX Φ0.20×0.6 mm 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. The following acupoints will be used: HT 7 (Shen Men), PC 6 (Nei Guan), Yin Tang (EX-HN 3), San Shang (55-02) (three point from Dong's acupuncture system) and the auricular Shen Men point. The treatment will use bilateral acupuncture (if patient's condition does not allow it, unilateral acupuncture will be done). The patient will lie in a supine position during the treatment. Acupuncturist will disinfect the acupoint location with an alcohol pad (70% alcohol), then the acupuncturist will press the needles sticker to the mentioned above acupoints. Interventions will be given on day 1, 3, and 5 after patient's enrolment.	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.; Other Names: Press Tack Needle/ sticker needle/PYONEX
Placebo Comparator: Control group (CON); Patients randomized to the control group will receive press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element. The point selection will be identical to acupuncture group: HT 7 (Shen Men), PC 6 (Nei Guan), Yin Tang (EX-HN 3), San Shang (55-02) (three point from Dong's acupuncture system) and the auricular Shen Men point. The treatment methods and patients position will be identical to acupuncture group. Interventions will be given on day 1, 3, and 5 after patient's enrolment.	Other: press tack placebo; press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element.; Other Names: PYONEX placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Acupuncture; Agitation; Delirium; Intensive care; Critically ill
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease Attributes; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Critical Illness
• Other Study ID Numbers: CMUH109-REC3-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No