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出境医 / 临床实验 / Medicine Acuity Patching Combined Massage in the Treatment of Patients With Acute Poisoning

Medicine Acuity Patching Combined Massage in the Treatment of Patients With Acute Poisoning

Study Description
Brief Summary:
This topic in western medicine combined on the basis of gastric lavage therapy in patients with acute poisoning acupoint sticking of traditional Chinese medicine and acupuncture point massage treatment, aims to smoothly accelerate cleaning and discharge poison, increase the poisoning patients rescue success rate, improve patient quality of life, for the clinical treatment of acute poisoning provides a new method of TCM nursing, to further exert TCM nursing characteristics.

Condition or disease Intervention/treatment Phase
Poisoning Patients Behavioral: acupoint massage and application Not Applicable

Detailed Description:
With the rapid development of national economy, people's exposure to a variety of chemicals, drugs and other opportunities to increase, the types of substances causing poisoning tend to be diversified, acute poisoning frequently occur. Data showed that in some regions of China, poisoning cases accounted for 2.7%~ 3.6% of the patients admitted to the emergency department in the same period , and 8.3 % of the patients rescued in the emergency department in the same period , and its fatality rate was higher than the total fatality rate in the emergency department . The incidence of poisoning was 18/100,000 in urban residents and 69.22/100,000 in rural areas, accounting for 10.7% of all deaths. Poisoning incident is an important part of national public health emergency management. According to the statistics of China's Ministry of Health in 2013, poisoning has entered the top five major causes of death in China, and the number of acute poisoning cases has been increasing year by year . The diagnosis and treatment of acute poisoning and the effective and rapid treatment have become an important task for emergency clinical workers.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study of Chinese Medicine Acuity Patching Combined Massage in the Treatment of Patients With Acute Poisoning and Stomach Washing
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: experimental group
Patients in the experimental group were treated with acupoint application combined with acupoint massage on the basis of standard treatment for acute poisoning. When the patient began to launder the stomach, the acupoint was applied to Shenque (umbilical). After the end of the gastric launder, Shenque acupoint and Zusanli diarrhea method (referring to counterclockwise and strong stimulation) were massaged for 15 minutes, and the massage frequency was Q8H.
 Behavioral: acupoint massage and application
Patients in the experimental group were treated with acupoint application combined with acupoint massage on the basis of standard treatment for acute poisoning. When the patient began to launder the stomach, the acupoint was applied to Shenque (umbilical). After the end of the gastric launder, Shenque acupoint and Zusanli diarrhea method (referring to counterclockwise and strong stimulation) were massaged for 15 minutes, and the massage frequency was Q8H.
No Intervention: control group
The treatment plan of control group was carried out according to the diagnosis and treatment standard of acute poisoning.
Outcome Measures
Primary Outcome Measures :
  1. complications [ Time Frame: one year ]
    Incidence of complications within 24 hours of admission: including nausea, vomiting, and abdominal pain

  2. Time of first bowel movement [ Time Frame: through study completion, an average of 1 year ]
    Time of first bowel movement

  3. patient duration of hospital stay [ Time Frame: through study completion, an average of 1 year ]
    patient duration of hospital stay


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with oral acute poisoning who were first diagnosed in our hospital and completed gastric lavage;
  2. The skin of umbilical cord and bilateral Zusanli acupoints had no injury, scar, rash and other skin diseases.
  3. The patient or the patient's family member signed the informed consent and expressed their willingness to receive treatment.

Exclusion Criteria:

  1. Patients with severe conditions requiring cardiopulmonary resuscitation or with severe trauma or multiple injuries;
  2. Patients with heart, brain, liver, kidney and hematopoietic system diseases and other serious primary diseases;
  3. Patients with a history of gastrointestinal diseases (such as postoperative cancer, intestinal obstruction, and large intestinal polyps) that affect gastrointestinal emptying;
  4. Failing to receive treatment according to regulations or taking poison again during hospitalization and unable to judge the curative effect.
Contacts and Locations

Contacts
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Contact: minfei yang +86 13757118252 2200056@zju.edu.cn

Locations
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China, Zhejiang
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Recruiting
Hanzhou, Zhejiang, China, 310000
Contact: minfei yang    +8613757118252    2200056@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: minfei yang 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Tracking Information
First Submitted Date  ICMJE June 18, 2021
First Posted Date  ICMJE June 28, 2021
Last Update Posted Date June 28, 2021
Actual Study Start Date  ICMJE March 8, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2021)
  • complications [ Time Frame: one year ]
    Incidence of complications within 24 hours of admission: including nausea, vomiting, and abdominal pain
  • Time of first bowel movement [ Time Frame: through study completion, an average of 1 year ]
    Time of first bowel movement
  • patient duration of hospital stay [ Time Frame: through study completion, an average of 1 year ]
    patient duration of hospital stay
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medicine Acuity Patching Combined Massage in the Treatment of Patients With Acute Poisoning
Official Title  ICMJE The Study of Chinese Medicine Acuity Patching Combined Massage in the Treatment of Patients With Acute Poisoning and Stomach Washing
Brief Summary This topic in western medicine combined on the basis of gastric lavage therapy in patients with acute poisoning acupoint sticking of traditional Chinese medicine and acupuncture point massage treatment, aims to smoothly accelerate cleaning and discharge poison, increase the poisoning patients rescue success rate, improve patient quality of life, for the clinical treatment of acute poisoning provides a new method of TCM nursing, to further exert TCM nursing characteristics.
Detailed Description With the rapid development of national economy, people's exposure to a variety of chemicals, drugs and other opportunities to increase, the types of substances causing poisoning tend to be diversified, acute poisoning frequently occur. Data showed that in some regions of China, poisoning cases accounted for 2.7%~ 3.6% of the patients admitted to the emergency department in the same period , and 8.3 % of the patients rescued in the emergency department in the same period , and its fatality rate was higher than the total fatality rate in the emergency department . The incidence of poisoning was 18/100,000 in urban residents and 69.22/100,000 in rural areas, accounting for 10.7% of all deaths. Poisoning incident is an important part of national public health emergency management. According to the statistics of China's Ministry of Health in 2013, poisoning has entered the top five major causes of death in China, and the number of acute poisoning cases has been increasing year by year . The diagnosis and treatment of acute poisoning and the effective and rapid treatment have become an important task for emergency clinical workers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Poisoning Patients
Intervention  ICMJE Behavioral: acupoint massage and application
Patients in the experimental group were treated with acupoint application combined with acupoint massage on the basis of standard treatment for acute poisoning. When the patient began to launder the stomach, the acupoint was applied to Shenque (umbilical). After the end of the gastric launder, Shenque acupoint and Zusanli diarrhea method (referring to counterclockwise and strong stimulation) were massaged for 15 minutes, and the massage frequency was Q8H.
Study Arms  ICMJE
  • Experimental: experimental group
    Patients in the experimental group were treated with acupoint application combined with acupoint massage on the basis of standard treatment for acute poisoning. When the patient began to launder the stomach, the acupoint was applied to Shenque (umbilical). After the end of the gastric launder, Shenque acupoint and Zusanli diarrhea method (referring to counterclockwise and strong stimulation) were massaged for 15 minutes, and the massage frequency was Q8H.
    Intervention: Behavioral: acupoint massage and application
  • No Intervention: control group
    The treatment plan of control group was carried out according to the diagnosis and treatment standard of acute poisoning.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2021) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with oral acute poisoning who were first diagnosed in our hospital and completed gastric lavage;
  2. The skin of umbilical cord and bilateral Zusanli acupoints had no injury, scar, rash and other skin diseases.
  3. The patient or the patient's family member signed the informed consent and expressed their willingness to receive treatment.

Exclusion Criteria:

  1. Patients with severe conditions requiring cardiopulmonary resuscitation or with severe trauma or multiple injuries;
  2. Patients with heart, brain, liver, kidney and hematopoietic system diseases and other serious primary diseases;
  3. Patients with a history of gastrointestinal diseases (such as postoperative cancer, intestinal obstruction, and large intestinal polyps) that affect gastrointestinal emptying;
  4. Failing to receive treatment according to regulations or taking poison again during hospitalization and unable to judge the curative effect.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: minfei yang +86 13757118252 2200056@zju.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04941859
Other Study ID Numbers  ICMJE 2021-0023
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: minfei yang 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP