Emergency PatientsNCT04951596
Management Standard of Bone Marrow Infusion in Acute and Critical Patients
An observational study of Emergency Patients, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emergency Patients
- What is being tested?
- Investigate the current situation
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Emergency medical staff 2. Bone marrow cavity catheterization patients
Who may be able to join
- 1.Emergency medical staffMore than two years of critical work experience 2.Volunteer to participate in research
Who cannot join
- Patients who have neurological disease
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310000
minfei yang, +8613757118252, 2200056@zju.edu.cn
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hanzhou, Zhejiang, 310000
minfei yang, +86 13757118252, 2200056@zju.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Emergency Patients
- Being tested
- Investigate the current situation
- Keywords
- Acute and critically ill patients, Intraosseous infusion, Management standards
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigate the current situationOther
Investigate the current situation of infusion treatment for acute and critical patients in 2 hospitals in the province
What is being measured
The primary outcome is the main question the study is designed to answer.
complications in patients with intraosseous infusion
The number of complications occurred in the bone marrow cavity was calculated
Measured: one and a half years
time of infufusion access establishment for patients
The time of catheterization for each bone marrow cavity puncture was recorded
Measured: one and a half years
Success rate of infusion access establishment
The success rate of establishing the infusion access was calculated
Measured: one and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Emergency PatientsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- minfei yang, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951596
- Sponsor's protocol ID
- 2020-170
- Status last verified
- Jan 2021
- First submitted
- 17 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22307192Wampler 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.
PubMed 22030185Link 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.
PubMed 26472995Whitney 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.
PubMed 28562239
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Value of Precision Management Standard of Bone Marrow Infusion in Acute and Critical Patients
- ClinicalTrials.gov ID
- NCT04951596
- Acronym / sponsor ID
- 2020-170
- Conditions
- Emergency Patients
- Keywords
- Acute and critically ill patients, Intraosseous infusion, Management standards
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Emergency medical staff 2. Bone marrow cavity catheterization patients
Key inclusion criteria (1 listed)
- 1.Emergency medical staffMore than two years of critical work experience 2.Volunteer to participate in research
Key exclusion criteria (1 listed)
- Patients who have neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigate the current situationInvestigate the current situation of infusion treatment for acute and critical patients in 2 hospitals in the province | Other | – |
Primary outcome
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
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
Success rate of infusion access establishment
Time frame: one and a half years
The success rate of establishing the infusion access was calculated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Results publication: PubMed 22307192Voigt 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.
- Results publication: PubMed 22030185Wampler 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.
- Results publication: PubMed 26472995Link 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.
- Results publication: PubMed 28562239Whitney 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
minfei yang principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Patients, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact minfei yang (+86 13757118252, 2200056@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications in patients with intraosseous infusion (time frame: one and a half years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04951596, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.