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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04950738
Other study ID # CMUH110-REC1-037
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date September 30, 2022

Study information

Verified date June 2021
Source China Medical University Hospital
Contact Yu-Chen Lee
Phone 04-22052121
Email d5167@mail.cmuh.org.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date September 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility 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.

Study Design


Intervention

Other:
pess 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.
pess tack placebo
pess tack stickers without a needle

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary arrhythmia incidence of arrhythmia at the patient's ICU discharge, on average 1 week
Primary 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
Primary feeding intolorance measured by days to reach the target Energy Fxpenditure at the patient's ICU discharge, on average 1 week
Primary 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
Primary 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
Primary dose of use of prokinetic drugs does of metoclopramide, Erythromycin or other prokinetic drugs at the patient's ICU discharge, on average 1 week
Primary 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
Primary 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 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 at the patient's ICU discharge, on average 1 week
Secondary the need for a post-pyloric tube patients who cannot digest with daily NG tube and by doctor decision at the patient's ICU discharge, on average 1 week
Secondary vomitus in microliters at the patient's ICU discharge, on average 1 week
Secondary diarrhea in microliters at the patient's ICU discharge, on average 1 week
Secondary constipation days 3 days without stool discharge at the patient's ICU discharge, on average 1 week
Secondary gastrointestinal (GI) bleeding in number of times at the patient's ICU discharge, on average 1 week
Secondary albumin blood levels serum albumin blood levels at the patient's ICU discharge, on average 1 week
Secondary Intravenous (IV) injected albumin IV injected albumin in grams at the patient's ICU discharge, on average 1 week
Secondary heart rate number of beats per minute day 1,3,5,7
Secondary blood pressure systolic and diastolic blood pressure in mm Hg day 1,3,5,7
Secondary SpO2 oxygen saturation Sp02 oxygen saturation levels day 1,3,5,7
Secondary Respiratory rate measured by number of breath in one minute day 1,3,5,7
Secondary mean arterial pressure average pressure in a patient's arteries during one cardiac cycle day 1,3,5,7
Secondary Body temperature number of days of body temperature over 38 °C at the patient's ICU discharge, on average 1 week
Secondary ventilator data ventilator data day 1,3,5,7
Secondary 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). at the patient Hospital discharge, on average 1 month
Secondary mechanical ventilation days days number of days under mechanical ventilation at the patient Hospital discharge, on average 1 month
Secondary ICU stay number of admission days to the ICU at the patient's ICU discharge, on average 1 week
Secondary hospital days number of admission days to the hospital at the patient Hospital discharge, on average 1 month
Secondary ICU mortality number of patients died in the ICU at the patient's ICU discharge, on average 1 week
Secondary Hospital mortality number of patients died in the hospital at the patient Hospital discharge, on average 1 month
Secondary cost of hospital admission cost of hospital admission in New Taiwan Dollars {TWD) at the patient Hospital discharge, on average 1 month
Secondary cost of ICU admission cost of ICU admission in New Taiwan Dollars {TWD). at the patient's ICU discharge, on average 1 week
Secondary acupuncturist blinding blinding questioner will ask the acupuncturist to which group he/she guessed he/she applied the intervention after intervention on day 5
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