ICUNJJLISTPNCT04944537
Current Situation and Analysis of ICU Management for Severe Trauma Patients in China
An observational study of ICU and Trauma Injury, run by Lulu Gu at 1 site in China.
Trial summary
Over the past 10 years, there has not been a consensus on ICU nursing management based on the concept of injury control. Case management for patients with serious trauma continues to be initiated in general services and after discharge.There is no critical care unit case management strategy for the high-risk… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ICU, Trauma Injury, ICU Acquired Weakness
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2021to 27 Dec 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Formally hired, and working in ICU for more than 6 months, with ICU trauma patient management experience
Who may be able to join
- Registered nurses, doctors, and rehabilitation technicians on the job;
- Formally hired, and working in ICU for more than 6 months, with ICU patient management experience;
- Voluntary participation in this survey.
Who cannot join
- retirees, interns/nurses/rehabilitation technicians, staff on leave, regular training doctors, and departmental nurses;
- those who are unwilling to participate in this survey.
Trial locations and contacts
1 site in 1 country.
China1 site
Jinling Hosp Res Inst of general surgery,Nanjing Univ Sch Med
Nanjing, Jiangsu, 210000
About this study
Official title: Current Situation and Analysis of ICU Management in Severe Trauma Patients: A Survey From 12 Provinces in China
Over the past 10 years, there has not been a consensus on ICU nursing management based on the concept of injury control. Case management for patients with serious trauma continues to be initiated in general services and after discharge.There is no critical care unit case management strategy for the high-risk population following acute intake. Consequently, there is an urgent need to develop and enhance ICU nursing best practice after injury control.
- Conditions
- ICU, Trauma Injury, ICU Acquired Weakness
- Being tested
- No Intervention
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| ICU management for patients with severe trauma | Group to investigate the current status of ICU management for patients with severe trauma Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition of ICU severe trauma patient
The management status of severe trauma patients: including 5 dimensions of risk factor management, related complications management, ICU transition ward preparation plan, discharge preparation plan, and doctor-patient communication
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start27 May 2021
- Primary completion27 Jun 2021 (estimated)
- Study completion27 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ICUStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lulu Gu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lulu Gu, Jinling Hospital, China
- Investigators
- Xianghong Ye, Principal investigator, Jinling Hosp Res Inst of general surgery,Nanjing Univ,Sch Med
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944537
- Sponsor's protocol ID
- 20210615
- Other IDs
- 18CXZ040
- Acronym
- NJJLISTP
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li ZL, Jin P, Yuan HH, Xu JF, Chen YJ, Wang ZQ, Li Z, Fang Y, Yu XD. Regional whole-course trauma care - Experiences from a county-level hospital. Chin J Traumatol. 2018 Oct;21(5):250-255. doi: 10.1016/j.cjtee.2018.08.001. Epub 2018 Aug 24.
PubMed 30270142Antunes PSL, LibOrio PR, Shimoda GM, Pivetta LGA, Parreira JG, Assef JC. Trauma Quality Indicators' usage limitations in severe trauma patients. Rev Col Bras Cir. 2021 Feb 24;48:e20202769. doi: 10.1590/0100-6991e-20202769. eCollection 2021.
PubMed 33656134Coccolini F, Kluger Y, Moore EE, Maier RV, Coimbra R, Ordonez C, Ivatury R, Kirkpatrick AW, Biffl W, Sartelli M, Hecker A, Ansaloni L, Leppaniemi A, Reva V, Civil I, Vega F, Chiarugi M, Chichom-Mefire A, Sakakushev B, Peitzman A, Chiara O, Abu-Zidan F, Maegele M, Miccoli M, Chirica M, Khokha V, Sugrue M, Fraga GP, Otomo Y, Baiocchi GL, Catena F; WSES Trauma Quality Indicators Expert Panel. Trauma quality indicators: internationally approved core factors for trauma management quality evaluation. World J Emerg Surg. 2021 Feb 23;16(1):6. doi: 10.1186/s13017-021-00350-7.
PubMed 33622373Tahan HM, Kurland M, Baker M. Understanding the Increasing Role and Value of the Professional Case Manager: A National Study From the Commission for Case Manager Certification: Part 1. Prof Case Manag. 2020 May/Jun;25(3):133-165. doi: 10.1097/NCM.0000000000000429.
PubMed 32235196Jeppesen E, Iversen VV, Hansen IS, Reierth E, Wisborg T. Trauma research in the Nordic countries, 1995-2018 - a systematic review. Scand J Trauma Resusc Emerg Med. 2020 Mar 12;28(1):20. doi: 10.1186/s13049-020-0703-6.
PubMed 32164776
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Situation and Analysis of ICU Management in Severe Trauma Patients: A Survey From 12 Provinces in China
- ClinicalTrials.gov ID
- NCT04944537
- Acronym / sponsor ID
- NJJLISTP / 20210615
- Conditions
- ICU, Trauma Injury, ICU Acquired Weakness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lulu GuUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 27 Jun 2021 (estimated)
- Study completion
- 27 Dec 2021 (estimated)
- First posted
- 29 Jun 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.
Over the past 10 years, there has not been a consensus on ICU nursing management based on the concept of injury control. Case management for patients with serious trauma continues to be initiated in general services and after discharge.There is no critical care unit case management strategy for the high-risk population following acute intake. Consequently, there is an urgent need to develop and enhance ICU nursing best practice after injury control.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU management for patients with severe trauma | – | Other: No InterventionGroup to investigate the current status of ICU management for patients with severe trauma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Formally hired, and working in ICU for more than 6 months, with ICU trauma patient management experience
Key inclusion criteria (3 listed)
- Registered nurses, doctors, and rehabilitation technicians on the job;
- Formally hired, and working in ICU for more than 6 months, with ICU patient management experience;
- Voluntary participation in this survey.
Key exclusion criteria (2 listed)
- retirees, interns/nurses/rehabilitation technicians, staff on leave, regular training doctors, and departmental nurses;
- those who are unwilling to participate in this survey.
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 |
|---|---|---|
| No InterventionNo Intervention | Other | ICU management for patients with severe trauma |
Primary outcome
Cognition of ICU severe trauma patient
Time frame: 20 days
The management status of severe trauma patients: including 5 dimensions of risk factor management, related complications management, ICU transition ward preparation plan, discharge preparation plan, and doctor-patient communication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Background: PubMed 30270142Li ZL, Jin P, Yuan HH, Xu JF, Chen YJ, Wang ZQ, Li Z, Fang Y, Yu XD. Regional whole-course trauma care - Experiences from a county-level hospital. Chin J Traumatol. 2018 Oct;21(5):250-255. doi: 10.1016/j.cjtee.2018.08.001. Epub 2018 Aug 24.
- Background: PubMed 33656134Antunes PSL, LibOrio PR, Shimoda GM, Pivetta LGA, Parreira JG, Assef JC. Trauma Quality Indicators' usage limitations in severe trauma patients. Rev Col Bras Cir. 2021 Feb 24;48:e20202769. doi: 10.1590/0100-6991e-20202769. eCollection 2021.
- Background: PubMed 33622373Coccolini F, Kluger Y, Moore EE, Maier RV, Coimbra R, Ordonez C, Ivatury R, Kirkpatrick AW, Biffl W, Sartelli M, Hecker A, Ansaloni L, Leppaniemi A, Reva V, Civil I, Vega F, Chiarugi M, Chichom-Mefire A, Sakakushev B, Peitzman A, Chiara O, Abu-Zidan F, Maegele M, Miccoli M, Chirica M, Khokha V, Sugrue M, Fraga GP, Otomo Y, Baiocchi GL, Catena F; WSES Trauma Quality Indicators Expert Panel. Trauma quality indicators: internationally approved core factors for trauma management quality evaluation. World J Emerg Surg. 2021 Feb 23;16(1):6. doi: 10.1186/s13017-021-00350-7.
- Background: PubMed 32235196Tahan HM, Kurland M, Baker M. Understanding the Increasing Role and Value of the Professional Case Manager: A National Study From the Commission for Case Manager Certification: Part 1. Prof Case Manag. 2020 May/Jun;25(3):133-165. doi: 10.1097/NCM.0000000000000429.
- Background: PubMed 32164776Jeppesen E, Iversen VV, Hansen IS, Reierth E, Wisborg T. Trauma research in the Nordic countries, 1995-2018 - a systematic review. Scand J Trauma Resusc Emerg Med. 2020 Mar 12;28(1):20. doi: 10.1186/s13049-020-0703-6.
- 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.
Xianghong Ye principal investigator
Jinling Hosp Res Inst of general surgery,Nanjing Univ,Sch Med
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU and Trauma Injury, run by Lulu Gu at 1 site 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 3 inclusion and 2 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 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition of ICU severe trauma patient (time frame: 20 days). 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 NCT04944537, which also lists 5 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 29 Jun 2021.