CT AngiographyNCT04440904
Anatomical Study of Aorta Balloon Occlusion Based on CT Angiography
An observational study of CT Angiography and Marker; Structural, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Aortic balloon occlusion can be used by emergency physicians to rescue patients with massive bleeding.The purpose of this study is to study the anatomical characteristics of aortic balloon occlusion based on aortic CT angiography, so as to provide evidence for improving the success rate of aortic balloon occlusion… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- CT Angiography, Marker; Structural
- What is being tested?
- CT workstation (Syngo Via VB10B, Siemens, Germany)
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We conduct an observational retrospective study.The patients underwent aortic CT angiography examination in the radiology department of the hospital from April to December in 2019.
Who may be able to join
- Complete full-length CTA scan of aorta
- Aged 18-70 years old
- No obvious tortuosity diagnosed by CT
Who cannot join
- Aortic dissection
- Aortic aneurysm
- Severe aortic malformation
- Severe aortic plaque
- History of aortic operation.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: Anatomical Study of Aorta Balloon Occlusion Based on CT Angiography：A Retrospective Study
Aortic balloon occlusion can be used by emergency physicians to rescue patients with massive bleeding.The purpose of this study is to study the anatomical characteristics of aortic balloon occlusion based on aortic CT angiography, so as to provide evidence for improving the success rate of aortic balloon occlusion guided by body surface markers.
Read the detailed description
Study Design:
This study is a retrospective descriptive study. The study will be conducted by Radiology Department, Second Affiliated Hospital, Zhejiang University.
Selection of patients:
The investigators included 57 patients who underwent enhanced contrast full-length aortic CTA scanning in the Radiology Department of Grade 3A General Hospital affiliated to a university from April to December 2019. Data of all participants following no apparent vascular tortuosity in CT diagnosis aged 18-70 years with contrast-enhanced computed tomography (CT) images of chest, abdomen, and pelvis from April to December in 2019 were analyzed. Participants whose images accompanied by vascular malformation, poor contrast enhancement, and history of aortic surgery were precluded.
Method General data of patients were collected through the hospital's electronic medical record system, including age, sex, height, weight, average body mass index ((Body Mass Index,BMI), history of surgery, etc.
The CTA examination of the participants' full aorta was performed with a 128-slice dual-energy CT scanner (Siemens, Germany), and the images were saved in the database. After screening the suitable participants, the images were transmitted to the CT workstation (Syngo VB10B Image processing system, Siemens, Germany). Multiplanar reconstruction, curvature plane reconstruction, and volume rendering were used for three-dimensional reconstruction. The diameters and lengths of blood vessels and the distances on the body surface were measured. The diameters of blood vessels included the diameter of the aorta at the edge of left subclavian artery, celiac trunk, lowest renal artery, and aortic bifurcation. The intravascular length included the lengths of zone I, zone II, zone III and the descending aorta. The length from the bilateral femoral artery puncture site to the midpoint of zone I and III, left subclavian artery, celiac trunk, lowest renal artery and aortic bifurcation, and the distances on the body surface included the distance from the bilateral femoral artery puncture site to the suprasternal notch, xiphoid process and umbilicus.
The results were described as mean ±standard deviation. SPSS20.0 software (IBM, USA) was used for analysis. Paired sample t-test was used to compare the differences between the left and right sides of the data. The difference was statistically significant when the P value was less than 0.05.
Data Management and Confidentiality Data Management: Using paper version for data management and storage. The person responsible for collecting paper version will input data in Excel database, summary paper and electronic versions for further statistical analysis and preservation.
Security measures: All records related to the identity of participants are to be confidential and not open to the public outside the scope of relevant laws or regulations.
Informed consent: This study is a retrospective study. Retrospective measurement of participants' previous aortic CTA imaging data does not infringe upon the interests of participants, so informed consent can be exempted.
Possible risks of participating in this study: disclosure of personal information.
Precautions against possible risks:
- All the experimental data of the paper version and the electronic version shall be kept by the person in charge of the test data.
- Close the measurement software in time after the end of the study, and confirm that the personal information has been cleared.
Intervention measures for possible risks:
If there is a disclosure of personal information, it is necessary to record the research report form and inform the person in charge of the research to intervene in time, and notify the Ethics Committee immediately.
- Conditions
- CT Angiography, Marker; Structural
- Being tested
- CT workstation (Syngo Via VB10B, Siemens, Germany)
- Keywords
- CT angiography, Aorta, Anatomy, Aortic balloon occlusion, Body surface markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT workstation (Syngo Via VB10B, Siemens, Germany)Device
Multiplanar reconstruction, curvature plane reconstruction, and volume rendering were used for three-dimensional reconstruction to measure the diameters and lengths of blood vessels and the distances on the body surface
| Study group | Role | What they receive |
|---|---|---|
| Characteristic of aortic length and body surface mark | The diameters and lengths of blood vessels and the distances on the body surface were measured by three-dimensional reconstruction using related Software on CT Workstation Receives: Device: CT workstation (Syngo Via VB10B, Siemens, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length from the bilateral femoral artery puncture site to the left subclavian artery, celiac trunk, lowest renal artery and aortic bifurcation
The lengths of the blood vessels were measured along the centerline of the blood vessels by multiplanar reconstruction and curvature plane reconstruction
Measured: within 24 hours
The distances on the body surface from the bilateral femoral artery puncture site to the suprasternal notch, xiphoid process and umbilicus
The distances between the body surface mark were measured by using volume-rendering reconstruction
Measured: within 24 hours
Secondary outcomes (3)
the length of zone I
defined as the distance from the left subclavian artery to the celiac trunk
Measured: within 24 hours
the length of zone II
defined as the distance from the celiac trunk to the lowest renal artery
Measured: within 24 hours
the length of zone III
defined as the distance from the lowest renal artery to the aortic bifurcation
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Apr 2019
- Primary completion31 Oct 2019
- Study completion31 Dec 2019
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 CT AngiographyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440904
- Sponsor's protocol ID
- 2019-333
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
White JM, Cannon JW, Stannard A, Markov NP, Spencer JR, Rasmussen TE. Endovascular balloon occlusion of the aorta is superior to resuscitative thoracotomy with aortic clamping in a porcine model of hemorrhagic shock. Surgery. 2011 Sep;150(3):400-9. doi: 10.1016/j.surg.2011.06.010.
PubMed 21878225Stannard A, Eliason JL, Rasmussen TE. Resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct for hemorrhagic shock. J Trauma. 2011 Dec;71(6):1869-72. doi: 10.1097/TA.0b013e31823fe90c. No abstract available.
PubMed 22182896Linnebur M, Inaba K, Haltmeier T, Rasmussen TE, Smith J, Mendelsberg R, Grabo D, Demetriades D. Emergent non-image-guided resuscitative endovascular balloon occlusion of the aorta (REBOA) catheter placement: A cadaver-based study. J Trauma Acute Care Surg. 2016 Sep;81(3):453-7. doi: 10.1097/TA.0000000000001106.
PubMed 27192466Okada Y, Narumiya H, Ishi W, Iiduka R. Anatomical landmarks for safely implementing resuscitative balloon occlusion of the aorta (REBOA) in zone 1 without fluoroscopy. Scand J Trauma Resusc Emerg Med. 2017 Jul 3;25(1):63. doi: 10.1186/s13049-017-0411-z.
PubMed 28673353Eliason JL, Derstine BA, Horbal SR, Wang NC, Holcombe SA, Chiu CH, Ross BE, Bromwell B, Morrison J, Wang SC. Computed tomography correlation of skeletal landmarks and vascular anatomy in civilian adult trauma patients: Implications for resuscitative endovascular balloon occlusion of the aorta. J Trauma Acute Care Surg. 2019 Jul;87(1S Suppl 1):S138-S145. doi: 10.1097/TA.0000000000002247.
PubMed 31246918
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Study of Aorta Balloon Occlusion Based on CT Angiography：A Retrospective Study
- ClinicalTrials.gov ID
- NCT04440904
- Acronym / sponsor ID
- 2019-333
- Conditions
- CT Angiography, Marker; Structural
- Keywords
- CT angiography, Aorta, Anatomy, Aortic balloon occlusion, Body surface markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Jun 2020 (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.
Aortic balloon occlusion can be used by emergency physicians to rescue patients with massive bleeding.The purpose of this study is to study the anatomical characteristics of aortic balloon occlusion based on aortic CT angiography, so as to provide evidence for improving the success rate of aortic balloon occlusion guided by body surface markers.
Detailed description
Study Design:
This study is a retrospective descriptive study. The study will be conducted by Radiology Department, Second Affiliated Hospital, Zhejiang University.
Selection of patients:
The investigators included 57 patients who underwent enhanced contrast full-length aortic CTA scanning in the Radiology Department of Grade 3A General Hospital affiliated to a university from April to December 2019. Data of all participants following no apparent vascular tortuosity in CT diagnosis aged 18-70 years with contrast-enhanced computed tomography (CT) images of chest, abdomen, and pelvis from April to December in 2019 were analyzed. Participants whose images accompanied by vascular malformation, poor contrast enhancement, and history of aortic surgery were precluded.
Method General data of patients were collected through the hospital's electronic medical record system, including age, sex, height, weight, average body mass index ((Body Mass Index,BMI), history of surgery, etc.
The CTA examination of the participants' full aorta was performed with a 128-slice dual-energy CT scanner (Siemens, Germany), and the images were saved in the database. After screening the suitable participants, the images were transmitted to the CT workstation (Syngo VB10B Image processing system, Siemens, Germany). Multiplanar reconstruction, curvature plane reconstruction, and volume rendering were used for three-dimensional reconstruction. The diameters and lengths of blood vessels and the distances on the body surface were measured. The diameters of blood vessels included the diameter of the aorta at the edge of left subclavian artery, celiac trunk, lowest renal artery, and aortic bifurcation. The intravascular length included the lengths of zone I, zone II, zone III and the descending aorta. The length from the bilateral femoral artery puncture site to the midpoint of zone I and III, left subclavian artery, celiac trunk, lowest renal artery and aortic bifurcation, and the distances on the body surface included the distance from the bilateral femoral artery puncture site to the suprasternal notch, xiphoid process and umbilicus.
The results were described as mean ±standard deviation. SPSS20.0 software (IBM, USA) was used for analysis. Paired sample t-test was used to compare the differences between the left and right sides of the data. The difference was statistically significant when the P value was less than 0.05.
Data Management and Confidentiality Data Management: Using paper version for data management and storage. The person responsible for collecting paper version will input data in Excel database, summary paper and electronic versions for further statistical analysis and preservation.
Security measures: All records related to the identity of participants are to be confidential and not open to the public outside the scope of relevant laws or regulations.
Informed consent: This study is a retrospective study. Retrospective measurement of participants' previous aortic CTA imaging data does not infringe upon the interests of participants, so informed consent can be exempted.
Possible risks of participating in this study: disclosure of personal information.
Precautions against possible risks:
- All the experimental data of the paper version and the electronic version shall be kept by the person in charge of the test data.
- Close the measurement software in time after the end of the study, and confirm that the personal information has been cleared.
Intervention measures for possible risks:
If there is a disclosure of personal information, it is necessary to record the research report form and inform the person in charge of the research to intervene in time, and notify the Ethics Committee immediately.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Characteristic of aortic length and body surface mark | – | Device: CT workstation (Syngo Via VB10B, Siemens, Germany)The diameters and lengths of blood vessels and the distances on the body surface were measured by three-dimensional reconstruction using related Software on CT Workstation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We conduct an observational retrospective study.The patients underwent aortic CT angiography examination in the radiology department of the hospital from April to December in 2019.
Key inclusion criteria (3 listed)
- Complete full-length CTA scan of aorta
- Aged 18-70 years old
- No obvious tortuosity diagnosed by CT
Key exclusion criteria (5 listed)
- Aortic dissection
- Aortic aneurysm
- Severe aortic malformation
- Severe aortic plaque
- History of aortic operation.
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 |
|---|---|---|
| CT workstation (Syngo Via VB10B, Siemens, Germany)Multiplanar reconstruction, curvature plane reconstruction, and volume rendering were used for three-dimensional reconstruction to measure the diameters and lengths of blood vessels and the distances on the body surface | Device | Characteristic of aortic length and body surface mark |
Primary outcome
The length from the bilateral femoral artery puncture site to the left subclavian artery, celiac trunk, lowest renal artery and aortic bifurcation
Time frame: within 24 hours
The lengths of the blood vessels were measured along the centerline of the blood vessels by multiplanar reconstruction and curvature plane reconstruction
The distances on the body surface from the bilateral femoral artery puncture site to the suprasternal notch, xiphoid process and umbilicus
Time frame: within 24 hours
The distances between the body surface mark were measured by using volume-rendering reconstruction
3 secondary outcomes
the length of zone I
Time frame: within 24 hours
the length of zone II
Time frame: within 24 hours
the length of zone III
Time frame: within 24 hours
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 22 Jun 2020.
- Background: PubMed 21878225White JM, Cannon JW, Stannard A, Markov NP, Spencer JR, Rasmussen TE. Endovascular balloon occlusion of the aorta is superior to resuscitative thoracotomy with aortic clamping in a porcine model of hemorrhagic shock. Surgery. 2011 Sep;150(3):400-9. doi: 10.1016/j.surg.2011.06.010.
- Background: PubMed 22182896Stannard A, Eliason JL, Rasmussen TE. Resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct for hemorrhagic shock. J Trauma. 2011 Dec;71(6):1869-72. doi: 10.1097/TA.0b013e31823fe90c. No abstract available.
- Background: PubMed 27192466Linnebur M, Inaba K, Haltmeier T, Rasmussen TE, Smith J, Mendelsberg R, Grabo D, Demetriades D. Emergent non-image-guided resuscitative endovascular balloon occlusion of the aorta (REBOA) catheter placement: A cadaver-based study. J Trauma Acute Care Surg. 2016 Sep;81(3):453-7. doi: 10.1097/TA.0000000000001106.
- Background: PubMed 28673353Okada Y, Narumiya H, Ishi W, Iiduka R. Anatomical landmarks for safely implementing resuscitative balloon occlusion of the aorta (REBOA) in zone 1 without fluoroscopy. Scand J Trauma Resusc Emerg Med. 2017 Jul 3;25(1):63. doi: 10.1186/s13049-017-0411-z.
- Background: PubMed 31246918Eliason JL, Derstine BA, Horbal SR, Wang NC, Holcombe SA, Chiu CH, Ross BE, Bromwell B, Morrison J, Wang SC. Computed tomography correlation of skeletal landmarks and vascular anatomy in civilian adult trauma patients: Implications for resuscitative endovascular balloon occlusion of the aorta. J Trauma Acute Care Surg. 2019 Jul;87(1S Suppl 1):S138-S145. doi: 10.1097/TA.0000000000002247.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 CT Angiography and Marker; Structural, 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 3 inclusion and 5 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 22 Jun 2020. 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?
The length from the bilateral femoral artery puncture site to the left subclavian artery, celiac trunk, lowest renal artery and aortic bifurcation (time frame: within 24 hours). The study lists 2 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 NCT04440904, 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 22 Jun 2020.