Clinical trial NCT04950738: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Agitation
Arrhythmia
Feeding Intolerance
Pain, Acute
Keywords: acupuncture
intensive care
delirium
agitation
double blinded randomized control study
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter parallel arm double-blind randomized control trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: arrhythmia
timeFrame: at the patient's ICU discharge, on average 1 week
measure: delirium
timeFrame: at the patient's ICU discharge, on average 1 week
measure: feeding intolorance
timeFrame: at the patient's ICU discharge, on average 1 week
measure: pain in the intensive care unit (ICU)
timeFrame: at the patient's ICU discharge, on average 1 week
measure: dose of arrhythmia drugs
timeFrame: at the patient's ICU discharge, on average 1 week
measure: dose of use of prokinetic drugs
timeFrame: at the patient's ICU discharge, on average 1 week
measure: analgesic medication use
timeFrame: at the patient's ICU discharge, on average 1 week
measure: delirium drug use
timeFrame: at the patient's ICU discharge, on average 1 week
Secondary outcomes:
measure: the use of Parental nutrition
timeFrame: at the patient's ICU discharge, on average 1 week
measure: the need for a post-pyloric tube
timeFrame: at the patient's ICU discharge, on average 1 week
measure: vomitus
timeFrame: at the patient's ICU discharge, on average 1 week
measure: diarrhea
timeFrame: at the patient's ICU discharge, on average 1 week
measure: constipation days
timeFrame: at the patient's ICU discharge, on average 1 week
measure: gastrointestinal (GI) bleeding
timeFrame: at the patient's ICU discharge, on average 1 week
measure: albumin blood levels
timeFrame: at the patient's ICU discharge, on average 1 week
measure: Intravenous (IV) injected albumin
timeFrame: at the patient's ICU discharge, on average 1 week
measure: heart rate
timeFrame: day 1,3,5,7
measure: blood pressure
timeFrame: day 1,3,5,7
measure: SpO2 oxygen saturation
timeFrame: day 1,3,5,7
measure: Respiratory rate
timeFrame: day 1,3,5,7
measure: mean arterial pressure
timeFrame: day 1,3,5,7
measure: Body temperature
timeFrame: at the patient's ICU discharge, on average 1 week
measure: ventilator data
timeFrame: day 1,3,5,7
measure: Overall Satisfaction of patient family
timeFrame: at the patient Hospital discharge, on average 1 month
measure: mechanical ventilation days days
timeFrame: at the patient Hospital discharge, on average 1 month
measure: ICU stay
timeFrame: at the patient's ICU discharge, on average 1 week
measure: hospital days
timeFrame: at the patient Hospital discharge, on average 1 month
measure: ICU mortality
timeFrame: at the patient's ICU discharge, on average 1 week
measure: Hospital mortality
timeFrame: at the patient Hospital discharge, on average 1 month
measure: cost of hospital admission
timeFrame: at the patient Hospital discharge, on average 1 month
measure: cost of ICU admission
timeFrame: at the patient's ICU discharge, on average 1 week
measure: acupuncturist blinding
timeFrame: after intervention on day 5
Other outcomes:
Locations:
Study officials:
affiliation: China Medical University Hospital
name: Yu-Chen Lee
role: PRINCIPAL_INVESTIGATOR
References: