The Effectiveness of Acupuncture for Complications in Critically Ill Patients

Delirium Clinical Trial

Official title:

The Effectiveness of Acupuncture for Complications in Critically Ill Patients: Multiple Centers a Double-Blind Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04950738
• Other study ID #: CMUH110-REC1-037
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Acute Pain
• Agitation
• Arrhythmia
• Delirium
• Feeding Intolerance
• Pain, Acute
• Psychomotor Agitation

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