Agitation, Arrhythmia, Delirium, Feeding Intolerance, Pain, Acute
Conditions
Keywords
acupuncture, intensive care, delirium, agitation, double blinded randomized control study
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.
Interventions
OTHERpess tack acupuncture
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.
OTHERpess tack placebo
pess tack stickers without a needle
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
multicenter parallel arm double-blind randomized control trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| arrhythmia | at the patient's ICU discharge, on average 1 week | incidence of arrhythmia |
| delirium | at the patient's ICU discharge, on average 1 week | 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 | at the patient's ICU discharge, on average 1 week | measured by days to reach the target Energy Fxpenditure |
| pain in the intensive care unit (ICU) | at the patient's ICU discharge, on average 1 week | 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 | at the patient's ICU discharge, on average 1 week | the dose of Adenosine, calcium channel blockers, or beta-blocking agents or other arrhythmia drugs . |
| dose of use of prokinetic drugs | at the patient's ICU discharge, on average 1 week | does of metoclopramide, Erythromycin or other prokinetic drugs |
| analgesic medication use | at the patient's ICU discharge, on average 1 week | dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications. |
| delirium drug use | at the patient's ICU discharge, on average 1 week | addition to drug use (a daily dose of sedative drugs, muscle relaxant, or atypical antipsychotics IV Haloperidol Benzodiazepines, Precedex, Propofol and oral Quediapine) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| heart rate | day 1,3,5,7 | number of beats per minute |
| blood pressure | day 1,3,5,7 | systolic and diastolic blood pressure in mm Hg |
| SpO2 oxygen saturation | day 1,3,5,7 | Sp02 oxygen saturation levels |
| Respiratory rate | day 1,3,5,7 | measured by number of breath in one minute |
| mean arterial pressure | day 1,3,5,7 | average pressure in a patient's arteries during one cardiac cycle |
| Body temperature | at the patient's ICU discharge, on average 1 week | number of days of body temperature over 38 °C |
| ventilator data | day 1,3,5,7 | ventilator data |
| Overall Satisfaction of patient family | at the patient Hospital discharge, on average 1 month | Overall Satisfaction of patient family will be measured by the European Family Satisfaction with Care in the Intensive Care Unit (EURO FS-ICU). |
| the use of Parental nutrition | at the patient's ICU discharge, on average 1 week | patients who cannot digest with daily NG tube: drainage: more than 500ml per day or severe diarrhea more the 1000 ml per day |
| ICU stay | at the patient's ICU discharge, on average 1 week | number of admission days to the ICU |
| hospital days | at the patient Hospital discharge, on average 1 month | number of admission days to the hospital |
| ICU mortality | at the patient's ICU discharge, on average 1 week | number of patients died in the ICU |
| Hospital mortality | at the patient Hospital discharge, on average 1 month | number of patients died in the hospital |
| cost of hospital admission | at the patient Hospital discharge, on average 1 month | cost of hospital admission in New Taiwan Dollars {TWD) |
| cost of ICU admission | at the patient's ICU discharge, on average 1 week | cost of ICU admission in New Taiwan Dollars {TWD). |
| acupuncturist blinding | after intervention on day 5 | blinding questioner will ask the acupuncturist to which group he/she guessed he/she applied the intervention |
| mechanical ventilation days days | at the patient Hospital discharge, on average 1 month | number of days under mechanical ventilation |
| the need for a post-pyloric tube | at the patient's ICU discharge, on average 1 week | patients who cannot digest with daily NG tube and by doctor decision |
| vomitus | at the patient's ICU discharge, on average 1 week | in microliters |
| diarrhea | at the patient's ICU discharge, on average 1 week | in microliters |
| constipation days | at the patient's ICU discharge, on average 1 week | 3 days without stool discharge |
| gastrointestinal (GI) bleeding | at the patient's ICU discharge, on average 1 week | in number of times |
| albumin blood levels | at the patient's ICU discharge, on average 1 week | serum albumin blood levels |
| Intravenous (IV) injected albumin | at the patient's ICU discharge, on average 1 week | IV injected albumin in grams |
Contacts
Primary ContactYu-Chen Lee
Backup ContactPeiyu Kao
Outcome results
None listed