The Role of Angiographic Measurements and Anatomical Correlations in Intra-Aortic Balloon Pump (IABP) Size Selection

NCT06947174 | Recruiting

• 1 other identifier: 928/2567(IRB4)
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study aim to accurately size the IABP size for patients. The main questions it aims to answer are:

• Are patients's height, jugular notch to transpyloric plane distance and distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray) are a good surrogate for IABP sizing?
• Is the distance obtained during a transfemoral artery catheterization a reliable way to size the IABP? Researchers will enroll patient who have had previous CT that include thoracic aorta to celiac trunk who will undergo transfemoral angiography.
• All patients that researcher enrolled will undergo transfemoral angiography, during which the researchers will measure the vessel distance using a wire after the procedure end.
• Researchers will measure the height weight, jugular notch to transpyloric plane distance, CXR distance from carina to upper border of L1 and the distance from aorta at subclavian level to celiac trunk from CT.
• Researchers will find the correlation between of each measurement to the distance from aorta at subclavian level to celiac trunk from CT (considered the standard measure).

Conditions

Intra-aortic Balloon Pump

Keywords

Intra-aortic balloon pump

Outcome Measures

Primary Outcomes (6)

• Height

  Height of the patients

  Day 1

• Weight

  Weight of the patient

  Day 1

• Jugular notch to transpyloric plane distance

  Distance from jugular notch to transpyloric plane (Horizontal plane between jugular notch to pubic symphysis)

  Day 1

• distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray)

  distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray)

  through study completion, an average of 1 year

• distance of left subclavian artery to celiac trunk measure from CT scan.

  distance of left subclavian artery to celiac trunk measure from CT scan.

  through study completion, an average of 1 year

• distance from the carina to the upper part of the first lumbar vertebra measure by wiring distance during transferal angiography

  Wiring distance is obtained during the transferal angiography after the procedure is done and when the operator take the wire out. Mesure at the carina level to the upper part of the first lumbar vertebra

  Day 1

Eligibility Criteria

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

Study Population

Patients undergoing transfemoral angiography at Siriraj cauterization lab.

You may qualify if:

• Patients had obtained CT scan of chest with upper abdomen with celiac trunk visualize within 1 year from the day of transfemoral angiography
• Patients had who will undergo transfemoral angiography as clinical indicated
• Patients had obtained Chest X-ray within 1 year from the day of transfemoral angiography

You may not qualify if:

• Patient with limb amputation
• Patient with known aortic abnormalities such as aortic aneurysm, aortic dissection

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (11)

• Yang IY, Oraee S, Viejo C, Stern H. Computed tomography celiac trunk topography relating to celiac plexus block. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):21-5. doi: 10.1097/AAP.0b013e318203067f.

  PMID: 21455084 BACKGROUND

• Kim JT, Lee JR, Kim JK, Yoon SZ, Jeon Y, Bahk JH, Kim KB, Kim CS, Lim YJ, Kim HS, Kim SD. The carina as a useful radiographic landmark for positioning the intraaortic balloon pump. Anesth Analg. 2007 Sep;105(3):735-8. doi: 10.1213/01.ane.0000278086.23266.35.

  PMID: 17717232 BACKGROUND

• Chaturvedi A, Rotman Y, Hoang T, Jew G, Mandalapu A, Narins C. CT and chest radiography in evaluation of mechanical circulatory support devices for acute heart failure. Insights Imaging. 2023 Jul 16;14(1):122. doi: 10.1186/s13244-023-01469-8.

  PMID: 37454301 BACKGROUND

• Rhodes NG, Johnson TF, Boyum JH, Khandelwal A, Howell BD, Froemming AT, Behfar A. Radiology of Intra-Aortic Balloon Pump Catheters. Radiol Cardiothorac Imaging. 2022 Apr 14;4(2):e210120. doi: 10.1148/ryct.210120. eCollection 2022 Apr.

  PMID: 35506140 BACKGROUND

• Parissis H, Soo A, Leotsinidis M, Dougenis D. A statistical model that predicts the length from the left subclavian artery to the celiac axis; towards accurate intra aortic balloon sizing. J Cardiothorac Surg. 2011 Aug 9;6:95. doi: 10.1186/1749-8090-6-95.

  PMID: 21827666 BACKGROUND

• Byon HJ, Kim H, Kim HC, Kim JT, Kim HS, Lee SC, Kim CS. Potential risk for intra-aortic balloon-induced obstruction to the celiac axis or the renal artery in the Asian population. Thorac Cardiovasc Surg. 2011 Mar;59(2):99-102. doi: 10.1055/s-0030-1250429. Epub 2011 Mar 7.

  PMID: 21384305 BACKGROUND

• Igari T. The length of the aorta from the subclavian artery to the renal artery based on computed tomographic measurements in Japanese adults. J Artif Organs. 2006;9(4):267-70. doi: 10.1007/s10047-006-0346-z. Epub 2006 Dec 21.

  PMID: 17171407 BACKGROUND

• Shin H, Yozu R, Sumida T, Kawada S. Acute ischemic hepatic failure resulting from intraaortic balloon pump malposition. Eur J Cardiothorac Surg. 2000 Apr;17(4):492-4. doi: 10.1016/s1010-7940(00)00366-3.

  PMID: 10773577 BACKGROUND

• Swartz MT, Sakamoto T, Arai H, Reedy JE, Salenas L, Yuda T, Standeven JW, Pennington DG. Effects of intraaortic balloon position on renal artery blood flow. Ann Thorac Surg. 1992 Apr;53(4):604-10. doi: 10.1016/0003-4975(92)90318-x.

  PMID: 1554268 BACKGROUND

• Rastan AJ, Tillmann E, Subramanian S, Lehmkuhl L, Funkat AK, Leontyev S, Doenst T, Walther T, Gutberlet M, Mohr FW. Visceral arterial compromise during intra-aortic balloon counterpulsation therapy. Circulation. 2010 Sep 14;122(11 Suppl):S92-9. doi: 10.1161/CIRCULATIONAHA.109.929810.

  PMID: 20837932 BACKGROUND

• Weber KT, Janicki JS. Intraaortic balloon counterpulsation. A review of physiological principles, clinical results, and device safety. Ann Thorac Surg. 1974 Jun;17(6):602-36. doi: 10.1016/s0003-4975(10)65706-2. No abstract available.

  PMID: 4601521 BACKGROUND

Study Officials

• Ploy Pengchata, Doctor of Medicine

  Her Majesty Cardiac Center, Faculty of Medicine Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Tisyakorn, Doctor of Medicine

CONTACT

+66925549747; james51236@gmail.com

Ploy Pengchata, Doctor of Medicine

CONTACT

+66894500223; ploypeng097@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 27, 2025
• Study Start: January 25, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 years after the study end
• Access Criteria: Data sharing upon reasonable request.

Locations

TH (1)