The Effectiveness of Acupuncture for Complications in Critically Ill Patients

NCT04950738 | Unknown

• 1 other identifier: CMUH110-REC1-037
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Delirium; Agitation; Arrhythmia; Feeding Intolerance; Pain, Acute

Keywords

acupuncture; intensive care; delirium; agitation; double blinded randomized control study

Outcome Measures

Primary Outcomes (8)

• arrhythmia

  incidence of arrhythmia

  at the patient's ICU discharge, on average 1 week

• 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.

  at the patient's ICU discharge, on average 1 week

• feeding intolorance

  measured by days to reach the target Energy Fxpenditure

  at the patient's ICU discharge, on average 1 week

• 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.

  at the patient's ICU discharge, on average 1 week

• dose of arrhythmia drugs

  the dose of Adenosine, calcium channel blockers, or beta-blocking agents or other arrhythmia drugs .

  at the patient's ICU discharge, on average 1 week

• dose of use of prokinetic drugs

  does of metoclopramide, Erythromycin or other prokinetic drugs

  at the patient's ICU discharge, on average 1 week

• analgesic medication use

  dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications.

  at the patient's ICU discharge, on average 1 week

• 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)

  at the patient's ICU discharge, on average 1 week

Secondary Outcomes (24)

• the use of Parental nutrition

  at the patient's ICU discharge, on average 1 week

• the need for a post-pyloric tube

  at the patient's ICU discharge, on average 1 week

• vomitus

  at the patient's ICU discharge, on average 1 week

• diarrhea

  at the patient's ICU discharge, on average 1 week

• constipation days

  at the patient's ICU discharge, on average 1 week

Study Arms (2)

Acupuncture with press tack needle group (Acu)

EXPERIMENTAL

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.

Other: pess tack acupuncture

Placebo group press tack placebo (Con)

PLACEBO COMPARATOR

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.

Other: pess tack placebo

Interventions

pess tack acupuncture OTHER

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.

Also known as: Press Tack Needle/ sticker needle/ PYONEX

Acupuncture with press tack needle group (Acu)

pess tack placebo OTHER

pess tack stickers without a needle

Also known as: PYONEX placebo

Placebo group press tack placebo (Con)

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20--90
• newly ICU admission (\<48 hours)
• APACHE score \<30
• Less than 3 inotropic medicine use
• Fi02\< 60%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Delirium; Psychomotor Agitation; Arrhythmias, Cardiac; Acute Pain

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pain

Study Officials

• Yu-Chen Lee

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Chen Lee

CONTACT

04-22052121; d5167@mail.cmuh.org.tw

Peiyu Kao

CONTACT

04-22052121; ludouto@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: multicenter parallel arm double-blind randomized control trial

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 6, 2021
• Study Start: August 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: September 30, 2022
• Last Updated: July 6, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share