- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04951596
Management Standard of Bone Marrow Infusion in Acute and Critical Patients
July 5, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Application Value of Precision Management Standard of Bone Marrow Infusion in Acute and Critical Patients
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
- 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.
- 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.
- 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.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: minfei yang
- Phone Number: +86 13757118252
- Email: 2200056@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
-
Contact:
- minfei yang
- Phone Number: +8613757118252
- Email: 2200056@zju.edu.cn
-
Hanzhou, Zhejiang, China, 310000
- Recruiting
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
-
Contact:
- minfei yang
- Phone Number: +86 13757118252
- Email: 2200056@zju.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- Emergency medical staff
- Bone marrow cavity catheterization patients
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complications in patients with intraosseous infusion
Time Frame: one and a half years
|
The number of complications occurred in the bone marrow cavity was calculated
|
one and a half years
|
time of infufusion access establishment for patients
Time Frame: one and a half years
|
The time of catheterization for each bone marrow cavity puncture was recorded
|
one and a half years
|
Success rate of infusion access establishment
Time Frame: one and a half years
|
The success rate of establishing the infusion access was calculated
|
one and a half years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: minfei yang, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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 Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available. Erratum In: Circulation. 2015 Dec 15;132(24):e385.
- 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.
- 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.2011.07.010. Epub 2011 Oct 24.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
June 17, 2021
First Submitted That Met QC Criteria
July 5, 2021
First Posted (Actual)
July 7, 2021
Study Record Updates
Last Update Posted (Actual)
July 7, 2021
Last Update Submitted That Met QC Criteria
July 5, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-170
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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