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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04951596
Other study ID # 2020-170
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 31, 2022

Study information

Verified date January 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact minfei yang
Phone +86 13757118252
Email 2200056@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

As the spike in the number and severity of patients with critical patients, then quickly effective transfusion treatment demand becomes more and more serious, and the pattern of infusion pathways have traditionally used already can not adapt to this change, therefore, an urgent need to establish a set of is in line with international standards and accord with the situation of our country is simple, effective and scientific accuracy of IO management solution. In order to ensure the safety of the treatment of acute and critical patients, and in the province and even domestic experts recognized and promoted the application.


Description:

1. Investigate the current situation of infusion treatment for critical and critical patients in two hospitals in the province, the cognition of medical staff in critical and critical units on IO, IO training and assessment, and continuous quality improvement, etc. A comprehensive understanding of the needs of medical staff in the acute critical care unit for the refined IO management standard, including the analysis of the application of the standard in some hospitals. 2. Clarify and refine the contents of relevant indexes of IO management standards to form a standardized, scientific, unified and simple way to quickly judge difficult vessels. Defining the appropriate infusion access, infusion tool, puncture site, infusion speed, infusion effect, patient outcome, complications, indications, contraindication, infusion risk management, relevant personnel training and assessment, and continuous quality improvement as indexes. 3. On the basis of the standards of existing guidelines, a reasonable observation time range and the number of puncture times consistent with the first infusion puncture were established.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 1.Emergency medical staffMore than two years of critical work experience 2.Volunteer to participate in research Exclusion Criteria: - Patients who have neurological disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Investigate the current situation
Investigate the current situation of infusion treatment for acute and critical patients in 2 hospitals in the province

Locations

Country Name City State
China 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang
China 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hanzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (4)

Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for — View Citation

Voigt J, Waltzman M, Lottenberg L. Intraosseous vascular access for in-hospital emergency use: a systematic clinical review of the literature and analysis. Pediatr Emerg Care. 2012 Feb;28(2):185-99. doi: 10.1097/PEC.0b013e3182449edc. Review. — View Citation

Wampler D, Schwartz D, Shumaker J, Bolleter S, Beckett R, Manifold C. Paramedics successfully perform humeral EZ-IO intraosseous access in adult out-of-hospital cardiac arrest patients. Am J Emerg Med. 2012 Sep;30(7):1095-9. doi: 10.1016/j.ajem.2011.07.01 — View Citation

Whitney R, Langhan M. Vascular Access in Pediatric Patients in the Emergency Department: Types of Access, Indications, and Complications. Pediatr Emerg Med Pract. 2017 Jun;14(6):1-20. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary complications in patients with intraosseous infusion The number of complications occurred in the bone marrow cavity was calculated one and a half years
Primary time of infufusion access establishment for patients The time of catheterization for each bone marrow cavity puncture was recorded one and a half years
Primary Success rate of infusion access establishment The success rate of establishing the infusion access was calculated one and a half years
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