Traditional Chinese Medicine for Complications in Critically Ill Patients

Not Applicable

• Conditions: Critically Ill Patients
• Interventions: Other: Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance

• Registration Number: NCT05458687
• Lead Sponsor: China Medical University Hospital

Brief Summary

The purpose of this study was to examine the impact of Chinese medicine on common problems in intensive care units.

Detailed Description

Introduction: Intensive care unit is a special department in the health care facility. Although with highly development of modern medicine nowadays, the average mortality rate in Intensive care unit is still around 7 to 20 %. There are a few tricky problems that intensivists and intensive care nurses faced very often, including intensive care unit delirium, arrythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients. Traditional Chinese Medicine can possibly provide a series of interventions that can alleviate those conditions.

Methods: A randomized control trial will examine the effect of traditional Chinese Medicine interventions vs. routine intensive care unit care. The patients will be randomly divided 1:1 into one of two groups. A total of 80 intensive care patient will have to meet the following criteria: age 20-90, two or less inotropic medicine use. Interventions such as: Chinese herbal medicine decoction, acupuncture, laser acupuncture, Chinese Tuina massage, herbal medicinal cake applied on acupoint, health education and diet education, will be given based on the patients needs and Traditional Chinese Medicine doctor decision. The main outcomes will be the incidence of arrythmia, delirium, and poor digestion and the severity of pain. The investigators will also record intensive care unit mortality, intensive care unit stays and hospital days.

Study Timeline

• Study Start: 2022-06-21
• Study First Submitted: 2022-06-28
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-12
• Last Update Submitted: 2022-07-12
• Study First Posted: 2022-07-14
• Last Update Posted: 2022-07-14
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age 20-90
• newly intensive care unit admission (<48 hours)
• Two or less inotropic medicine prescribed

Exclusion Criteria

• Clinically unstable: receiving more than inotropic agents.
• Coagulopathy: Prolong Prothrombin Time、activated Partial Thromboplastin Time more than 4 times

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Chinese herbal medicine decoction、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application、Nursing/Diet and health education and guidance	* Chinese herbal medicine decoction. * Acupuncture or Laser acupuncture pen treatment. * Acupoint Tuina massage. * Acupoint application of traditional Chinese herbal medicinal cake. * Nursing and health education and guidance. * Diet and health education.

Primary Outcome Measures

Name	Time	Method
The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain.	ICDSC、RASS、BPS record by everyday.	For delirium use the Intensive Care Delirium Screening Checklist (ICDSC) score of:0\~8.; And Richmond Agitation-Sedation Scale (RASS) score of: -5\~+4. For pain use the Behavioral pain scale(BPS) score of:3\~12.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan