Anatomical Study of Aorta Balloon Occlusion Based on CT Angiography

NCT04440904 | Completed DMC

• 1 other identifier: 2019-333
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CT Angiography; Marker; Structural

Keywords

CT angiography; Aorta; Anatomy; Aortic balloon occlusion; Body surface markers

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• the length of zone I

  within 24 hours

• the length of zone II

  within 24 hours

• the length of zone III

  within 24 hours

Study Arms (1)

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

Device: CT workstation (Syngo Via VB10B, Siemens, Germany)

Interventions

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

Characteristic of aortic length and body surface mark

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Complete full-length CTA scan of aorta
• Aged 18-70 years old
• No obvious tortuosity diagnosed by CT

You may not qualify if:

• Aortic dissection
• Aortic aneurysm
• Severe aortic malformation
• Severe aortic plaque
• History of aortic operation.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (5)

• 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.

  PMID: 21878225 BACKGROUND

• 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. No abstract available.

  PMID: 22182896 BACKGROUND

• 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.

  PMID: 27192466 BACKGROUND

• 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.

  PMID: 28673353 BACKGROUND

• 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.

  PMID: 31246918 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 22, 2020
• Study Start: April 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

CN (1)