Severe TraumaNCT04938674
Author-Wang Ping-- Research：Application of Ultrasonic Guided Puncture in Blood Collection in Patients With Severe Trauma
An observational study of Severe Trauma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aimed to investigate the application of ultrasound guided puncture technique in blood collection in patients with severe trauma. The methods of this study is 93 patients with severe trauma were selected from the emergency room of the Second Affiliated Hospital of Zhejiang University from April 2020 to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Trauma
- What is being tested?
- ultrasonic guidance
- Type of treatment
- Medical device
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 1 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with severe trauma received in the emergency room of the Second Affiliated Hospital of Zhejiang University Medical College from April 2020 to March 2021
Who may be able to join
- ① airway obstruction, need tracheal intubation or intubation;② breathing stop, respiratory distress or significant slowing down;③ circulatory system shows various shock signs④GCS≤8;⑤ body table visible head, torso, chest open injury or yoke chest
Who cannot join
- All patients who stop the rescue room trauma evaluation and treatment midway through hospital transfer and automatic discharge
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Zhejiang, Zhejiang, 310000
About this study
Official title: Application of Ultrasonic Guided Puncture in Blood Collection in Patients With Severe Trauma
This study aimed to investigate the application of ultrasound guided puncture technique in blood collection in patients with severe trauma. The methods of this study is 93 patients with severe trauma were selected from the emergency room of the Second Affiliated Hospital of Zhejiang University from April 2020 to September 2,2020 and from October 2020 to March 2021, comparing the differences between nursing treatment efficiency and doctor satisfaction.
Read the detailed description
Standard process for blood collection using Ultrasonic Guided puncture.The control group used the traditional blood sample collection process, which was mainly based on personal clinical experience.
Statistical analysis using SPSS 25.0 statistical software. Observation index are time index of nursing treatment for patients with severe trauma: the time required for acquisition time, disposable puncture success rate, blood routine and blood type delivery time, rescue room stay time, etc and patient family and doctor satisfaction analysis: self-designed questionnaire, family satisfaction process, service time, service attitude, rescue technology, health education, including advice time, nursing quality, medical communication, teamwork, service attitude, evaluation levels: very satisfaction, satisfaction and dissatisfaction.
- Conditions
- Severe Trauma
- Being tested
- ultrasonic guidance
- Keywords
- ultrasound guidance, severe trauma, nursing care, blood specimen collection
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonic guidanceDevice
Standard process for blood collection using Ultrasonic Guided puncture
| Study group | Role | What they receive |
|---|---|---|
| Standard process for blood collection using Ultrasonic Guided puncture | Not described Receives: Device: ultrasonic guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction analysis of the patient's family members
In contrast to the control group,patient family satisfaction survey includes medical time. The evaluation level is divided into 3 categories: very satisfied, satisfactory and unsatisfactory.
Measured: 1 year
Time index of nursing treatment for patients with severe trauma
In contrast to the control group,time required for blood collection in patients with severe trauma
Measured: 1 year
Satisfaction analysis of the doctors
In contrast to the control group,physician satisfaction survey includes executive advice time.The evaluation level is divided into 3 categories: very satisfied, satisfactory and unsatisfactory
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Apr 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe TraumaStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Ze Xin, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938674
- Sponsor's protocol ID
- 2021-0272
- Status last verified
- Apr 2020
- First submitted
- 2 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Ultrasonic Guided Puncture in Blood Collection in Patients With Severe Trauma
- ClinicalTrials.gov ID
- NCT04938674
- Acronym / sponsor ID
- 2021-0272
- Conditions
- Severe Trauma
- Keywords
- ultrasound guidance, severe trauma, nursing care, blood specimen collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 24 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.
This study aimed to investigate the application of ultrasound guided puncture technique in blood collection in patients with severe trauma. The methods of this study is 93 patients with severe trauma were selected from the emergency room of the Second Affiliated Hospital of Zhejiang University from April 2020 to September 2,2020 and from October 2020 to March 2021, comparing the differences between nursing treatment efficiency and doctor satisfaction.
Detailed description
Standard process for blood collection using Ultrasonic Guided puncture.The control group used the traditional blood sample collection process, which was mainly based on personal clinical experience.
Statistical analysis using SPSS 25.0 statistical software. Observation index are time index of nursing treatment for patients with severe trauma: the time required for acquisition time, disposable puncture success rate, blood routine and blood type delivery time, rescue room stay time, etc and patient family and doctor satisfaction analysis: self-designed questionnaire, family satisfaction process, service time, service attitude, rescue technology, health education, including advice time, nursing quality, medical communication, teamwork, service attitude, evaluation levels: very satisfaction, satisfaction and dissatisfaction.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard process for blood collection using Ultrasonic Guided puncture | – | Device: ultrasonic guidance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with severe trauma received in the emergency room of the Second Affiliated Hospital of Zhejiang University Medical College from April 2020 to March 2021
Key inclusion criteria (1 listed)
- ① airway obstruction, need tracheal intubation or intubation;② breathing stop, respiratory distress or significant slowing down;③ circulatory system shows various shock signs④GCS≤8;⑤ body table visible head, torso, chest open injury or yoke chest
Key exclusion criteria (1 listed)
- All patients who stop the rescue room trauma evaluation and treatment midway through hospital transfer and automatic discharge
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 |
|---|---|---|
| ultrasonic guidanceStandard process for blood collection using Ultrasonic Guided puncture | Device | Standard process for blood collection using Ultrasonic Guided puncture |
Primary outcome
Satisfaction analysis of the patient's family members
Time frame: 1 year
In contrast to the control group,patient family satisfaction survey includes medical time. The evaluation level is divided into 3 categories: very satisfied, satisfactory and unsatisfactory.
Time index of nursing treatment for patients with severe trauma
Time frame: 1 year
In contrast to the control group,time required for blood collection in patients with severe trauma
Satisfaction analysis of the doctors
Time frame: 1 year
In contrast to the control group,physician satisfaction survey includes executive advice time.The evaluation level is divided into 3 categories: very satisfied, satisfactory and unsatisfactory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- 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.
Chen Ze Xin principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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 Severe Trauma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 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: finished, as of the sponsor's last update on 24 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Satisfaction analysis of the patient's family members (time frame: 1 year). 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?
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 24 Jun 2021.