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

April 19, 2025 updated by: James Tisyakorn, Siriraj Hospital

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).

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background:

  • Intra-aortic balloon pumps (IABP) are commonly used as mechanical circulatory support in patient with cariogenic shock.
  • Proper sizing of IABP is critical, critical, with the balloon typically extending from the left subclavian artery to the celiac axis, and occupying 90-95% of the aorta's diameter during each cycle.
  • Manufacturers usually recommend balloon sizes based on patient height. However, previous studies suggest that the accuracy of these recommendations varies. One study found that while chest X-ray (CXR) confirmed correct balloon positioning in 96.8% of cases, only 38.1% were accurately positioned based on CT scans.
  • Malposition of the balloon, such as blocking the renal or mesenteric arteries, may lead to complications like renal or intra-abdominal ischemia
  • Cadaveric studies have suggested that the distance from the jugular notch to the transpyloric plane correlates more strongly with the subclavian-to-celiac artery distance than height alone
  • A Chinese study attempted to predict the left subclavian artery to celiac trunk distance using a combination of height, body mass index (BMI), and age
  • In this study, investigators want to find the better way in sizing IABP balloon. Investigators with use the height, age, weight, jugular notch to transpyloric plane distance, distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray) and length of the vessel measured during transfemoral angiography compare with distance of the vessel measure during CT-scan.

Outcome

  • Investigators will find the correlation between height, jugular notch to transpyloric plane distance, wire pull out distance from aortic knob to L1 in angiographic study and distance of left subclavian artery to celiac trunk measure from CT aorta using Pearson Correlation or Spearman rank statistics.
  • Referencing previous studies

The correlation coefficient between height and the distance to the LCA-celiac trunk was 0.369 , and the correlation coefficient between height and the distance to the LCA-renal artery was 0.579 (Igari T. The length of the aorta from the subclavian artery to the renal artery based on computed tomographic measurements in Japanese adults. Journal of Artificial Organs. 2006;9:267-70.). The researcher chose to use the lower correlation coefficient of 0.369 for calculating sample size to achieve a maximum sample size.Using the formula for calculating sample size for correlation coefficient testing, with a standard value of 1.96 set at a significance level of 5% and a power of 80%, the sample size was calculated as follows:

  • Fisher's Z Transformation from formula = = 1/2 ln((1+(0.369))/(1-(0.369)))= 0.387 Calculate sample size by n= ((1.96+0.84)/(0.387))^2+3 n = 56 Sample size from this calculation is 56, it was determined that an additional sample size of 56 participants is needed, with a further increase of 20% to account for potential data loss, resulting in an additional 12 participants, totaling 68 individuals. Therefore, the sample size used in this study is 68 participants Recruitments - Investigators will review patients scheduled for angiography to determine if they have had a CT chest scan that includes the celiac trunk and are eligible for the study.

Inclusion criteria are

  1. Patient age ≥ 18 years old
  2. Patients had obtained CT scan of chest with upper abdomen with celiac trunk visualize within 1 year from the day of transfemoral angiography
  3. Patients had who will undergo transfemoral angiography as clinical indicated
  4. Patients had obtained Chest X-ray within 1 year from the day of transfemoral angiography Exclusion criteria are

1. Patient with limb amputation 2. Patient with known aortic abnormalities such as aortic aneurysm, aortic dissection Study procedure

  • Before the patient's arrival at the catheterization lab, the investigator will seek their consent to participate in the study.
  • Patients will be informed that their treatment will proceed as usual, with the only additional step being a request for the procedure operator to measure the pullback wire distance at the end of the procedure. This step will result in slightly more radiation exposure but will take less than one minute to complete and does not increase the procedural risk.
  • If the operator determines that the patient is unstable, the measurement will not be performed. Patients who choose not to participate will still receive their standard treatment without any changes.
  • Other measurements such as height weight will be collected per Cath lab protocol.
  • The measurement of jugular notch to transpyloric plane distance will be collect at the recovery ward.

Study Type

Observational

Enrollment (Estimated)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
        • Contact:
        • Contact:
        • Contact:
          • Ploy Pengchata, Doctor of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing transfemoral angiography at Siriraj cauterization lab.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height
Time Frame: Day 1
Height of the patients
Day 1
Weight
Time Frame: Day 1
Weight of the patient
Day 1
Jugular notch to transpyloric plane distance
Time Frame: Day 1
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)
Time Frame: through study completion, an average of 1 year
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.
Time Frame: through study completion, an average of 1 year
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
Time Frame: Day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Principal Investigator: Ploy Pengchata, Doctor of Medicine, Her Majesty Cardiac Center, Faculty of Medicine Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 19, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 19, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 928/2567(IRB4)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

2 years after the study end

IPD Sharing Access Criteria

Data sharing upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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