NCT04950738

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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	pess tack placebo	pess tack stickers without a needle

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-07-30
• Completion: 2022-09-30
• First posted: 2021-07-06
• Last updated: 2021-07-06