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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03791333
Other study ID # PUPH20181127
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2021

Study information

Verified date December 2018
Source Peking University People's Hospital
Contact Peng ZHANG, Doctor
Phone 13001061778
Email hcooh2001@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Trauma is a major medical and public health problem facing all countries in the world today. Trauma is the leading cause of death worldwide for people under 45 years of age, and more than 5 million people die each year from severe trauma. According to the "China Injury Prevention Report" issued by the Ministry of Health in August 2007, about 200 million injuries occur annually in China, with 700,000 to 750,000 deaths, accounting for about 9% of the total number of deaths. Serious trauma has the characteristics of high mortality and disability rate, and often affects the main groups of young and middle-aged people of social labor force. It has a tremendous impact on social and economic development, and has brought a heavy burden to society and families. The treatment of severe trauma is extremely important, and its treatment process needs a standardized model. In many links of trauma treatment, accurate assessment of injury is the precondition of classification and grading of diagnosis and treatment, and also provides a good basis for the follow-up standardized treatment of patients. The accuracy and consistency of injury assessment are also the reflection of diagnosis and treatment ability. ISS score is an evaluation method for severe trauma and multiple trauma patients. It has been used by emergency personnel for a long time. It also plays a very good auxiliary role in the evaluation and treatment of patients'injuries. However, there are still many problems in the clinical use of ISS scores: 1. Some hospitals do not attach importance to the application of ISS scores, and do not fully understand the scoring method; 2. Low frequency of use, inaccurate grasp of the method; 3. Three-level physicians have different valuations of ISS scores for the same kind of trauma; 4. Use AIS scoring table to calculate. It takes a long time to calculate the ISS score, which affects the normal first aid efficiency. To this end, our research team designed a questionnaire on the use of ISS score. The main purpose of the questionnaire is to assess and register the severity of injury in multiple trauma patients to understand the current use and proficiency of ISS score system by Chinese trauma surgeons, the difference of ISS score between three-level doctors and the same patient, and ISS score. The consistency between the software and AIS scoring table and the scoring time of the two methods are also discussed. This study hopes that through this survey, we can understand the current situation of the application of the scoring system in Chinese hospitals, in order to promote the standardization of severe trauma assessment and promote the use of the evaluation system in hospitals throughout the country, so as to provide optimized trauma treatment process for trauma patients.


Description:

1. Research Background and Basis for Project Establishment* Trauma is a major medical and public health problem facing all countries in the world today. Trauma is the leading cause of death worldwide for people under 45 years of age, and more than 5 million people die each year from severe trauma. According to the "China Injury Prevention Report" issued by the Ministry of Health in August 2007, about 200 million injuries occur annually in China, with 700,000 to 750,000 deaths, accounting for about 9% of the total number of deaths. Serious trauma has the characteristics of high mortality and disability rate, and often affects the main groups of young and middle-aged people of social labor force. It has a tremendous impact on social and economic development, and has brought a heavy burden to society and families. The treatment of severe trauma is extremely important, and its treatment process needs a standardized model. In many links of trauma treatment, accurate assessment of injury is the precondition of classification and grading of diagnosis and treatment, and also provides a good basis for the follow-up standardized treatment of patients. The accuracy and consistency of injury assessment are also the reflection of diagnosis and treatment ability. ISS score is an evaluation method for severe trauma and multiple trauma patients. It has been used by emergency personnel for a long time. It also plays a very good auxiliary role in the evaluation and treatment of patients'injuries. However, there are still many problems in the assessment of severe trauma in various parts of China. It is difficult to adapt to the needs of the current medical and health system reform and to meet the needs of the society for the assessment of severe trauma. In the clinical use of ISS scoring, the main problems are as follows: 1. Some hospitals do not attach importance to the application of ISS scoring, and do not fully understand the scoring method; 2. The use of low frequency, inaccurate grasp of the method; 3. Three-level physicians have different evaluation of ISS scoring for the same kind of trauma; 4. Applying AIS scoring table to calculate ISS scoring. It takes a long time to share the time, which affects the normal first aid efficiency.

2. Research purposes * By assessing and registering the severity of multiple trauma patients, we can understand and improve the ability of different hospitals and doctors at different levels in different regions to assess the severity of multiple trauma patients, and promote the use of ISS scoring system in national trauma centers. In order to improve the level of understanding of multiple trauma patients and lay a foundation for the establishment of scientific classification and sorting and treatment system.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3600
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 1.Age not less than 18 years old; 2. Multiple trauma patients; 3. Complete auxiliary examination data of various trauma sites.

Exclusion Criteria:

- Patients who died on the spot or came to hospital; pregnant and lying-in women.

Study Design


Intervention

Other:
injury severity score
injury severity score of multi trauma patients

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

References & Publications (4)

Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. — View Citation

Jennett B. The Glasgow Coma Scale: History and current practice. Trauma, 2002, 4(2):91-103.

Kirkpatrick JR, Youmans RL. Trauma index. An aide in the evaluation of injury victims. J Trauma. 1971 Aug;11(8):711-4. — View Citation

Koehler JJ, Baer LJ, Malafa SA, Meindertsma MS, Navitskas NR, Huizenga JE. Prehospital Index: a scoring system for field triage of trauma victims. Ann Emerg Med. 1986 Feb;15(2):178-82. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ISS score of third-level surgeons for the same patient ISS score of third-level surgeons for the same patient 3 years
Primary Scoring time Scoring spending time 3 years
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