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NCT Number: NCT07305051

Study Of Ultrasound Windows For Measuring Inferior Vena Cava Changes Before Cardiac Surgery

This research study will compare two ultrasound methods for assessing the inferior vena cava (IVC), a major vein that reflects intravascular fluid status and cardiac function before and after surgery. The standard method uses a subcostal ultrasound view obtained below the breastbone, but this approach may be limited in patients with obesity, surgical dressings, or postoperative discomfort. An alternative approach, the transhepatic view, uses the liver as an acoustic window and may provide improved feasibility in these situations.

The study will evaluate whether the transhepatic view provides measurements comparable to the standard subcostal view and whether operators with different levels of ultrasound experience obtain consistent results using both methods. Adult patients who are awake and scheduled for cardiac surgery at Sunnybrook Health Sciences Centre will undergo a brief ultrasound examination before surgery. The scan takes less than 10 minutes, involves no discomfort, and does not alter clinical care. This is a minimal-risk observational study with no therapeutic interventions. Participation is voluntary, and all personal health information will remain confidential. Findings may inform future approaches to ultrasound-guided assessment and training in perioperative care.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Respiratory variation in inferior vena cava (IVC) diameter is a widely accepted non-invasive marker of intravascular volume status and fluid responsiveness, particularly in spontaneously breathing patients. Among transthoracic echocardiographic windows, this variation is most commonly assessed using the subcostal (SC) view, which is considered the clinical reference standard due to its direct acoustic pathway and extensive validation in research and clinical practice. The physiologic basis for this measure is strongest in the context of spontaneous respiration, where negative intrathoracic pressure significantly influences venous return dynamics. For this reason, the study population is limited to spontaneously breathing patients to ensure physiologic consistency and interpretive validity.

The SC view, however, may be limited by factors such as body habitus, postoperative dressings, or an obstructed subxiphoid window. The transhepatic (TH) view has been proposed as a complementary or alternative approach, providing an oblique acoustic window through the liver that facilitates visualization of the IVC long axis. Several observational studies have reported strong correlation and agreement between TH and SC measurements of IVC diameter and collapsibility, including in both spontaneously breathing and mechanically ventilated patients. Despite these promising findings, prior studies have been constrained by small sample sizes, heterogeneous methodologies, and limited assessment of reproducibility-particularly across operators with different levels of ultrasound experience. These gaps underscore the need for a larger, methodologically rigorous validation study.

The primary objective of this prospective, single-center observational study is to evaluate agreement between the SC and TH views using methodological standards aligned with diagnostic accuracy frameworks such as QUADAS-2, in a larger cohort of patients scheduled for cardiac surgery. The secondary objective is to assess interrater reliability of TH and SC IVC measurements obtained by novice and expert sonographers. The results are intended to strengthen the evidence base supporting the use of the transhepatic view in perioperative care and to inform future training, competency assessment, and quality-assurance processes in point-of-care ultrasound.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged eighteen years or older
  • Scheduled to undergo cardiac surgery at Sunnybrook Health Sciences Centre
  • Spontaneously breathing at the time of ultrasound assessment
  • Able to lie supine for image acquisition
  • Able to provide written informed consent

Exclusion criteria

  • Inability to lie supine
  • Known right heart failure
  • Moderate to severe tricuspid regurgitation
  • Portal hypertension
  • End-stage renal disease
  • Presence of abdominal dressings or conditions that preclude transhepatic imaging
  • Poor acoustic windows that prevent adequate measurement from either the subcostal or transhepatic view, despite standard optimization techniques (positioning, breathing coaching, depth and gain adjustment, probe angulation)

Treatment and study plan

Primary outcomes

  1. Agreement for collapsibility index (cIVC) between transhepatic and subcostal views

    Time frame: Preoperative period, within twenty-four to forty-eight hours before cardiac surgery.

    Outcome Metric: Intraclass correlation coefficient (ICC) for the collapsibility index (unitless).

    Rationale: To determine agreement between transhepatic and subcostal cIVC measurements.

Secondary outcomes

  1. Inter-rater reliability for transhepatic collapsibility index (cIVC)

    Time frame: Preoperative period, during the same imaging session.

    Metric: ICC(2,1) for cIVC (unitless).

    Rationale: To assess reproducibility between novice and expert sonographers.

  2. Agreement for IVC maximum diameter (IVCmax)

    Time frame: Preoperative period, during the same imaging session.

    Metrics: ICC for IVC maximum diameter (millimetres). Rationale: To determine whether transhepatic and subcostal measurements of IVC maximum diameter demonstrate sufficient agreement to support interchangeable use of the two ultrasound views for this parameter.

  3. Bland-Altman analysis for IVC diameter ratio (IVCmax:IVCmin)

    Time frame: Preoperative period, during the same imaging session.

    Outcome Metric:

    Bland-Altman bias and limits of agreement for the IVC diameter ratio (unitless).

    Rationale:

    To assess systematic bias and variability in the ratio of IVC maximum to minimum diameter across the two ultrasound views, offering an additional perspective on agreement in dynamic IVC behavior.

Other outcomes

  1. Agreement for IVC minimum diameter (IVCmin)

    Time frame: Preoperative period, during the same imaging session.

    Outcome Metric:

    Intraclass correlation coefficient (ICC) for IVC minimum diameter (millimetres).

    Rationale:

    To evaluate the agreement between transhepatic and subcostal measurements of IVC minimum diameter, which contributes to understanding the consistency of static diameter assessment across imaging windows.

  2. Agreement for IVC diameter ratio (IVCmax:IVCmin)

    Time frame: Preoperative period, during the same imaging session.

    Outcome Metric:

    Intraclass correlation coefficient (ICC) for the ratio of IVC maximum to IVC minimum diameter (unitless).

    Rationale:

    To assess agreement for the proportional relationship between maximum and minimum IVC diameters, providing additional information on dynamic venous diameter behavior across ultrasound views.

  3. Bland-Altman analysis for collapsibility index (cIVC)

    Time frame: Preoperative period, during the same imaging session.

    Outcome Metric:

    Bland-Altman bias and limits of agreement for the collapsibility index (unitless).

    Rationale:

    To quantify systematic bias and random variation between transhepatic and subcostal collapsibility index measurements, complementing correlation-based agreement metrics.

  4. Bland-Altman analysis for IVC maximum diameter

    Time frame: Preoperative period, during the same imaging session.

    Outcome Metric:

    Bland-Altman bias and limits of agreement for IVC maximum diameter (millimeters).

    Rationale:

    To characterize systematic differences and dispersion between transhepatic and subcostal measurements of IVC maximum diameter, informing clinical interpretability of any observed discrepancies.

  5. Bland-Altman analysis for IVC minimum diameter

    Time frame: Preoperative period, during the same imaging session.

    Outcome Metric:

    Bland-Altman bias and limits of agreement for IVC minimum diameter (millimeters).

    Rationale:

    To evaluate the magnitude and spread of measurement differences in IVC minimum diameter between transhepatic and subcostal views, providing a detailed assessment of potential measurement error.

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio Erbetta, MD

CONTACT

[email protected]

416-967-8587

Lilia Kaustov, MSc, PhD

CONTACT

[email protected]

416-967-8587

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

Comparison of Transhepatic and Subcostal Views for Assessing Inferior Vena Cava Diameter Variation in Cardiac Surgery Patients

Acronym: THRIVE-CARD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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