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The Effectiveness of Acupuncture for Delirium in Critically Ill Patients

Primary Purpose

Intensive Care Unit Delirium, Delirium, Agitation

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture (Press Tack Needle)
press tack placebo
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intensive Care Unit Delirium focused on measuring Acupuncture, Critically ill, Intensive care, Delirium, Agitation

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • medical and surgical intensive care department, medical and the surgical ward of China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acupuncture group (ACU)

Control group (CON)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 13, 2020
Last Updated
August 2, 2021
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04312893
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Delirium, Delirium, Agitation
Keywords
Acupuncture, Critically ill, Intensive care, Delirium, Agitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups, randomized, pre-post intervention study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Our study goal is the measure the effectiveness of press tack needles (acupuncture group) in reducing delirium severity in critically ill patients in the ICU. In order to ensure a double bind procedure, we will implement the use of press tack placebos (control group) as a competitor. In addition to the mentioned above interventions, patients in both groups will receive routine ICU care as per individual patient's needs.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture group (ACU)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (CON)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupuncture (Press Tack Needle)
Other Intervention Name(s)
Press Tack Needle/ sticker needle/PYONEX
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
press tack placebo
Other Intervention Name(s)
PYONEX placebo
Intervention Description
press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element.
Primary Outcome Measure Information:
Title
Intensive Care Delirium Screening Checklist
Description
A common delirium examination in the intensive care unit lowest score:1 ,highest score:8 , a score of 4 or higher indicates delirium
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Richmond Agitation-Sedation Scale
Description
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
Time Frame
4 weeks
Title
mechanical ventilation in days
Description
mechanical ventilation day is at least 5 hours under ventilator
Time Frame
4 weeks
Title
intensive care unit (ICU) stay in days
Description
number of days a patient stays in the intensive care unit
Time Frame
4 weeks
Title
hospital stay in days
Description
number of days a patient stays in the hospital
Time Frame
4 weeks
Title
intensive care unit (ICU) mortality
Description
the number of patients die in the intensive care unit (ICU)
Time Frame
4 weeks
Title
hospital mortality
Description
the number of patients die in the hospital
Time Frame
4 weeks
Title
drug use
Description
daily dose of: sedative drugs, muscle relaxant or atypical antipsychotics
Time Frame
4 weeks
Title
Blood pressure
Description
patients systolic and diastolic blood pressure
Time Frame
one hour before the interventions
Title
heart rate
Description
patients heart rate
Time Frame
one hour before the interventions
Title
Blood pressure
Description
patients systolic and diastolic blood pressure
Time Frame
one hour after the interventions
Title
heart rate
Description
patients heart rate
Time Frame
one hour after the interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
medical and surgical intensive care department, medical and the surgical ward of China Medical University Hospital
City
Taichung
ZIP/Postal Code
404472
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiyu Kao, M.D.
Phone
+886910698942
Email
ludouto@gmail.com
First Name & Middle Initial & Last Name & Degree
Eyal Ben-Arie, M.S.
Phone
+886989172041
Email
benarie19@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effectiveness of Acupuncture for Delirium in Critically Ill Patients

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