Anatomical Study of Aorta Balloon Occlusion Based on CT Angiography

CT Angiography Clinical Trial

Official title:

Anatomical Study of Aorta Balloon Occlusion Based on CT Angiography：A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440904
• Other study ID #: 2019-333
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 guided by body surface markers.

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:

1. All the experimental data of the paper version and the electronic version shall be kept by the person in charge of the test data.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Complete full-length CTA scan of aorta

• Aged 18-70 years old

• No obvious tortuosity diagnosed by CT

Exclusion Criteria:

• Aortic dissection

• Aortic aneurysm

• Severe aortic malformation

• Severe aortic plaque

• History of aortic operation.

Related Conditions & MeSH terms

• CT Angiography
• Marker; Structural

Intervention

Device:
• 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

Locations

Country	Name	City	State
China	Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (5)

Eliason 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. — View Citation

Linnebur 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. — View Citation

Okada 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. — View Citation

Stannard 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 24 hours
Primary	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	within 24 hours
Secondary	the length of zone I	defined as the distance from the left subclavian artery to the celiac trunk	within 24 hours
Secondary	the length of zone II	defined as the distance from the celiac trunk to the lowest renal artery	within 24 hours
Secondary	the length of zone III	defined as the distance from the lowest renal artery to the aortic bifurcation	within 24 hours