The Effectiveness of Acupuncture for Complications in Critically Ill Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium; Arrhythmia; Pain, Acute; Agitation; Feeding Intolerance
• Intervention / Treatment: Other: pess tack acupuncture; Other: pess tack placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Chen Lee; Phone Number: 04-22052121; Email: d5167@mail.cmuh.org.tw
• Study Contact Backup: Name: Peiyu Kao; Phone Number: 04-22052121; Email: ludouto@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture with press tack needle group (Acu); 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.	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.; Other Names: Press Tack Needle/ sticker needle/ PYONEX
Placebo Comparator: Placebo group press tack placebo (Con); 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.	Other: pess tack placebo; pess tack stickers without a needle; Other Names: PYONEX placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arrhythmia	incidence of arrhythmia	at the patient's ICU discharge, on average 1 week
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
feeding intolorance	measured by days to reach the target Energy Fxpenditure	at the patient's ICU discharge, on average 1 week
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
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
dose of use of prokinetic drugs	does of metoclopramide, Erythromycin or other prokinetic drugs	at the patient's ICU discharge, on average 1 week
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
vomitus	in microliters	at the patient's ICU discharge, on average 1 week
diarrhea	in microliters	at the patient's ICU discharge, on average 1 week
constipation days	3 days without stool discharge	at the patient's ICU discharge, on average 1 week
gastrointestinal (GI) bleeding	in number of times	at the patient's ICU discharge, on average 1 week
albumin blood levels	serum albumin blood levels	at the patient's ICU discharge, on average 1 week
Intravenous (IV) injected albumin	IV injected albumin in grams	at the patient's ICU discharge, on average 1 week
heart rate	number of beats per minute	day 1,3,5,7
blood pressure	systolic and diastolic blood pressure in mm Hg	day 1,3,5,7
SpO2 oxygen saturation	Sp02 oxygen saturation levels	day 1,3,5,7
Respiratory rate	measured by number of breath in one minute	day 1,3,5,7
mean arterial pressure	average pressure in a patient's arteries during one cardiac cycle	day 1,3,5,7
Body temperature	number of days of body temperature over 38 °C	at the patient's ICU discharge, on average 1 week
ventilator data	ventilator data	day 1,3,5,7
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
mechanical ventilation days days	number of days under mechanical ventilation	at the patient Hospital discharge, on average 1 month
ICU stay	number of admission days to the ICU	at the patient's ICU discharge, on average 1 week
hospital days	number of admission days to the hospital	at the patient Hospital discharge, on average 1 month
ICU mortality	number of patients died in the ICU	at the patient's ICU discharge, on average 1 week
Hospital mortality	number of patients died in the hospital	at the patient Hospital discharge, on average 1 month
cost of hospital admission	cost of hospital admission in New Taiwan Dollars {TWD)	at the patient Hospital discharge, on average 1 month
cost of ICU admission	cost of ICU admission in New Taiwan Dollars {TWD).	at the patient's ICU discharge, on average 1 week
acupuncturist blinding	blinding questioner will ask the acupuncturist to which group he/she guessed he/she applied the intervention	after intervention on day 5

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Yu-Chen Lee, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: delirium; acupuncture; intensive care; agitation; double blinded randomized control study
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Pain; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Acute Pain
• Other Study ID Numbers: CMUH110-REC1-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No