The Effectiveness of Acupuncture for Complications in Critically Ill Patients

China Medical University

Status: Unknown

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

Treatments: Other: pess tack acupuncture; Other: pess tack placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04950738

CMUH110-REC1-037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Acupuncture with press tack needle group (Acu)

Experimental group

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.

Treatment:

Other: pess tack acupuncture

Placebo group press tack placebo (Con)

Placebo Comparator group

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.

Treatment:

Other: pess tack placebo