search
Back to results

The Effectiveness of Acupuncture for Complications in Critically Ill Patients

Primary Purpose

Delirium, Agitation, Arrhythmia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pess tack acupuncture
pess tack placebo
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Delirium focused on measuring acupuncture, intensive care, delirium, agitation, double blinded randomized control study

Eligibility Criteria

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

Inclusion Criteria:

  • Age 20--90

    • newly ICU admission (<48 hours)
    • APACHE score <30
    • Less than 3 inotropic medicine use
    • Fi02< 60%.

Exclusion Criteria:

  • • Coagulopathy: Prolong Prothrombin Time (PPT) activated Partial Thromboplastin Time (aPTT) more than 4 times

    • Thrombocytopenia - low platelet count
    • Clinically unstable: receiving two or more inotropic agents or Fraction of Inspired Oxygen (Fi02) >60%
    • Primary central nervous system disorder: stroke, traumatic brain injury, central nervous system infections, brain tumors, recent intracranial surgery
    • Already under other traditional medicine intervention during hospitalization
    • Skin damage of more than 20% of the body skin.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Acupuncture with press tack needle group (Acu)

    Placebo group press tack placebo (Con)

    Arm Description

    Patients in acupuncture group will receive traditional Chinese acupuncture using Press Tack Needle (PYONEX 0.20 x l.5mm made by Seirin Corporation). The following acupoints will be used: HT 7 (Shen Men), PC 6 (Nei Guan), LU 9 (Tai yuan), LI 4 (He Gu), SP 3 (Tai Bai,) ST 44 (Nei ting), LIV 3 (Tai Chong). The treatment will use bilateral acupuncture Interventions will be given on day 1, 3, and 5 after patient's enrolment.

    Patients randomized to the control group will receive a press lack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element. The point selection will be identical to the acupuncture group: HT 7 (Shen Men), PC 6 (Nei Guan), LU 9 (Tai yuan), L1 4 (He Gu), SP 3; (Tat Bai), ST 44 (Ne1 tmg), LIV 3 (Tat Chong). Interventions will be given on days 1, 3, and 5 after the patient's enrolment.

    Outcomes

    Primary Outcome Measures

    arrhythmia
    incidence of arrhythmia
    delirium
    4 or more points according to the Intensive Care Delirium Screening Checklist (ICDSC)(0-8 scale, score of less than 4 points indicate no delirium, 4 or more indicate delirium) and a Richmond Agitation-Sedation Scale (RASS) score of: +l, +2, +3, +4 - 1, -2 (score meanings +1 - 4 = levels of agitation, -1-4= levels of sudation, 0 = normal mental state.
    feeding intolorance
    measured by days to reach the target Energy Fxpenditure
    pain in the intensive care unit (ICU)
    For pain the Numeric Rating scale will be applied in patients that are able to express their self. As well as the Behavioral pain scale. The Critical Care Pain Observation Tool (CPOT) 0-8, will also be filled by the doctor and nurses along with the dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications.
    dose of arrhythmia drugs
    the dose of Adenosine, calcium channel blockers, or beta-blocking agents or other arrhythmia drugs .
    dose of use of prokinetic drugs
    does of metoclopramide, Erythromycin or other prokinetic drugs
    analgesic medication use
    dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications.
    delirium drug use
    addition to drug use (a daily dose of sedative drugs, muscle relaxant, or atypical antipsychotics IV Haloperidol Benzodiazepines, Precedex, Propofol and oral Quediapine)

    Secondary Outcome Measures

    the use of Parental nutrition
    patients who cannot digest with daily NG tube: drainage: more than 500ml per day or severe diarrhea more the 1000 ml per day
    the need for a post-pyloric tube
    patients who cannot digest with daily NG tube and by doctor decision
    vomitus
    in microliters
    diarrhea
    in microliters
    constipation days
    3 days without stool discharge
    gastrointestinal (GI) bleeding
    in number of times
    albumin blood levels
    serum albumin blood levels
    Intravenous (IV) injected albumin
    IV injected albumin in grams
    heart rate
    number of beats per minute
    blood pressure
    systolic and diastolic blood pressure in mm Hg
    SpO2 oxygen saturation
    Sp02 oxygen saturation levels
    Respiratory rate
    measured by number of breath in one minute
    mean arterial pressure
    average pressure in a patient's arteries during one cardiac cycle
    Body temperature
    number of days of body temperature over 38 °C
    ventilator data
    ventilator data
    Overall Satisfaction of patient family
    Overall Satisfaction of patient family will be measured by the European Family Satisfaction with Care in the Intensive Care Unit (EURO FS-ICU).
    mechanical ventilation days days
    number of days under mechanical ventilation
    ICU stay
    number of admission days to the ICU
    hospital days
    number of admission days to the hospital
    ICU mortality
    number of patients died in the ICU
    Hospital mortality
    number of patients died in the hospital
    cost of hospital admission
    cost of hospital admission in New Taiwan Dollars {TWD)
    cost of ICU admission
    cost of ICU admission in New Taiwan Dollars {TWD).
    acupuncturist blinding
    blinding questioner will ask the acupuncturist to which group he/she guessed he/she applied the intervention

    Full Information

    First Posted
    June 22, 2021
    Last Updated
    June 25, 2021
    Sponsor
    China Medical University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04950738
    Brief Title
    The Effectiveness of Acupuncture for Complications in Critically Ill Patients
    Official Title
    The Effectiveness of Acupuncture for Complications in Critically Ill Patients: Multiple Centers a Double-Blind Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    July 30, 2022 (Anticipated)
    Study Completion Date
    September 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) is a special department in the health care facility. Although with high development of modern medicine nowadays, the average mortality rate in ICU is still around 7 to 20 %. There are a few tricky problems that intensivists and ICU nurses faced very often, including ICU delirium, arrhythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients. Methods: A 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 patients will have to meet the following criteria: age 20-90, newly ICU admission(<48 hours), APACHE score <30, one or no inotropic medicine use, FiO2< 60%. Three interventions will be given in each group. The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain. We will also record ICU mortality, ICU stays and hospital days.
    Detailed Description
    Introduction: Intensive care unit (ICU) is a special department in the health care facility. Although with high development of modern medicine nowadays, the average mortality rate in ICU is still around 7 to 20 %. There are a few tricky problems that intensivists and ICU nurses faced very often, including ICU delirium, arrhythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients. Methods: A 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 patients will have to meet the following criteria: age 20-90, newly ICU admission(<48 hours), APACHE score <30, one or no inotropic medicine use, FiO2< 60%. Three interventions will be given in each group. The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain. We will also record ICU mortality, ICU stays and hospital days. Expected outcome: The study finding will help to determine the therapeutic effect of acupuncture for ICU complications. Other information: This study will be conducted in the ICU departments of China medical hospital and Asia University 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delirium, Agitation, Arrhythmia, Feeding Intolerance, Pain, Acute
    Keywords
    acupuncture, intensive care, delirium, agitation, double blinded randomized control study

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    multicenter parallel arm double-blind randomized control trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture with press tack needle group (Acu)
    Arm Type
    Experimental
    Arm Description
    Patients in acupuncture group will receive traditional Chinese acupuncture using Press Tack Needle (PYONEX 0.20 x l.5mm made by Seirin Corporation). The following acupoints will be used: HT 7 (Shen Men), PC 6 (Nei Guan), LU 9 (Tai yuan), LI 4 (He Gu), SP 3 (Tai Bai,) ST 44 (Nei ting), LIV 3 (Tai Chong). The treatment will use bilateral acupuncture Interventions will be given on day 1, 3, and 5 after patient's enrolment.
    Arm Title
    Placebo group press tack placebo (Con)
    Arm Type
    Placebo Comparator
    Arm Description
    Patients randomized to the control group will receive a press lack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element. The point selection will be identical to the acupuncture group: HT 7 (Shen Men), PC 6 (Nei Guan), LU 9 (Tai yuan), L1 4 (He Gu), SP 3; (Tat Bai), ST 44 (Ne1 tmg), LIV 3 (Tat Chong). Interventions will be given on days 1, 3, and 5 after the patient's enrolment.
    Intervention Type
    Other
    Intervention Name(s)
    pess tack acupuncture
    Other Intervention Name(s)
    Press Tack Needle/ sticker needle/ PYONEX
    Intervention Description
    Patients enrolled will receive intervention in a form of either press tack acupuncture needles or press tack placebos. Three total intervention sessions will be taken place on day 1,3,5 from patient's enrolment. Needles/placebos skin withdrawal will be done 48 hours after treatment by an acupuncture doctor or by a trained ICU nurne. In cases when a patient will be transferred from the ICU, the 3 study interventions will be continued in the new ward.
    Intervention Type
    Other
    Intervention Name(s)
    pess tack placebo
    Other Intervention Name(s)
    PYONEX placebo
    Intervention Description
    pess tack stickers without a needle
    Primary Outcome Measure Information:
    Title
    arrhythmia
    Description
    incidence of arrhythmia
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    delirium
    Description
    4 or more points according to the Intensive Care Delirium Screening Checklist (ICDSC)(0-8 scale, score of less than 4 points indicate no delirium, 4 or more indicate delirium) and a Richmond Agitation-Sedation Scale (RASS) score of: +l, +2, +3, +4 - 1, -2 (score meanings +1 - 4 = levels of agitation, -1-4= levels of sudation, 0 = normal mental state.
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    feeding intolorance
    Description
    measured by days to reach the target Energy Fxpenditure
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    pain in the intensive care unit (ICU)
    Description
    For pain the Numeric Rating scale will be applied in patients that are able to express their self. As well as the Behavioral pain scale. The Critical Care Pain Observation Tool (CPOT) 0-8, will also be filled by the doctor and nurses along with the dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications.
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    dose of arrhythmia drugs
    Description
    the dose of Adenosine, calcium channel blockers, or beta-blocking agents or other arrhythmia drugs .
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    dose of use of prokinetic drugs
    Description
    does of metoclopramide, Erythromycin or other prokinetic drugs
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    analgesic medication use
    Description
    dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications.
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    delirium drug use
    Description
    addition to drug use (a daily dose of sedative drugs, muscle relaxant, or atypical antipsychotics IV Haloperidol Benzodiazepines, Precedex, Propofol and oral Quediapine)
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Secondary Outcome Measure Information:
    Title
    the use of Parental nutrition
    Description
    patients who cannot digest with daily NG tube: drainage: more than 500ml per day or severe diarrhea more the 1000 ml per day
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    the need for a post-pyloric tube
    Description
    patients who cannot digest with daily NG tube and by doctor decision
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    vomitus
    Description
    in microliters
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    diarrhea
    Description
    in microliters
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    constipation days
    Description
    3 days without stool discharge
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    gastrointestinal (GI) bleeding
    Description
    in number of times
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    albumin blood levels
    Description
    serum albumin blood levels
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    Intravenous (IV) injected albumin
    Description
    IV injected albumin in grams
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    heart rate
    Description
    number of beats per minute
    Time Frame
    day 1,3,5,7
    Title
    blood pressure
    Description
    systolic and diastolic blood pressure in mm Hg
    Time Frame
    day 1,3,5,7
    Title
    SpO2 oxygen saturation
    Description
    Sp02 oxygen saturation levels
    Time Frame
    day 1,3,5,7
    Title
    Respiratory rate
    Description
    measured by number of breath in one minute
    Time Frame
    day 1,3,5,7
    Title
    mean arterial pressure
    Description
    average pressure in a patient's arteries during one cardiac cycle
    Time Frame
    day 1,3,5,7
    Title
    Body temperature
    Description
    number of days of body temperature over 38 °C
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    ventilator data
    Description
    ventilator data
    Time Frame
    day 1,3,5,7
    Title
    Overall Satisfaction of patient family
    Description
    Overall Satisfaction of patient family will be measured by the European Family Satisfaction with Care in the Intensive Care Unit (EURO FS-ICU).
    Time Frame
    at the patient Hospital discharge, on average 1 month
    Title
    mechanical ventilation days days
    Description
    number of days under mechanical ventilation
    Time Frame
    at the patient Hospital discharge, on average 1 month
    Title
    ICU stay
    Description
    number of admission days to the ICU
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    hospital days
    Description
    number of admission days to the hospital
    Time Frame
    at the patient Hospital discharge, on average 1 month
    Title
    ICU mortality
    Description
    number of patients died in the ICU
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    Hospital mortality
    Description
    number of patients died in the hospital
    Time Frame
    at the patient Hospital discharge, on average 1 month
    Title
    cost of hospital admission
    Description
    cost of hospital admission in New Taiwan Dollars {TWD)
    Time Frame
    at the patient Hospital discharge, on average 1 month
    Title
    cost of ICU admission
    Description
    cost of ICU admission in New Taiwan Dollars {TWD).
    Time Frame
    at the patient's ICU discharge, on average 1 week
    Title
    acupuncturist blinding
    Description
    blinding questioner will ask the acupuncturist to which group he/she guessed he/she applied the intervention
    Time Frame
    after intervention on day 5

    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 newly ICU admission (<48 hours) APACHE score <30 Less than 3 inotropic medicine use Fi02< 60%. Exclusion Criteria: • Coagulopathy: Prolong Prothrombin Time (PPT) activated Partial Thromboplastin Time (aPTT) more than 4 times Thrombocytopenia - low platelet count Clinically unstable: receiving two or more inotropic agents or Fraction of Inspired Oxygen (Fi02) >60% Primary central nervous system disorder: stroke, traumatic brain injury, central nervous system infections, brain tumors, recent intracranial surgery Already under other traditional medicine intervention during hospitalization Skin damage of more than 20% of the body skin.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu-Chen Lee
    Phone
    04-22052121
    Email
    d5167@mail.cmuh.org.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peiyu Kao
    Phone
    04-22052121
    Email
    ludouto@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu-Chen Lee
    Organizational Affiliation
    China Medical University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effectiveness of Acupuncture for Complications in Critically Ill Patients

    We'll reach out to this number within 24 hrs