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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability to lie supine

Known right heart failure

Moderate to severe tricuspid regurgitation

Portal hypertension

Trial population

The study population consists of adult patients scheduled to undergo elective cardiac surgery at Sunnybrook Health Sciences Centre. Eligible participants will be spontaneously breathing and able to lie supine during ultrasound assessment. The study will include male and female patients aged eighteen years or older, with no upper age limit. Exclusion criteria focus on conditions that impair accurate visualization of the inferior vena cava, including right heart failure, significant tricuspid regurgitation, portal hypertension, end-stage renal disease, obstructive dressings, or inadequate acoustic windows despite optimization maneuvers. This population reflects typical perioperative cardiac surgery patients in whom reliable non-invasive assessment of fluid status is clinically relevant.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

283 Participants
are grouped into 1 trial group
Group A: Adult Cardiac Surgery Patients

Trial outcomes

Primary outcomes

1

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

Outcome Metric: Intraclass correlation coefficient (ICC) for the collapsibility index (unitless). Rationale: To determine agreement between transhepatic and subcostal cIVC measurements.

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

Secondary outcomes

1

Inter-rater reliability for transhepatic collapsibility index (cIVC)

Metric: ICC(2,1) for cIVC (unitless). Rationale: To assess reproducibility between novice and expert sonographers.

Time frame
Preoperative period, during the same imaging session.
2

Agreement for IVC maximum diameter (IVCmax)

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.

Time frame
Preoperative period, during the same imaging session.
3

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

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.

Time frame
Preoperative period, during the same imaging session.

Other outcomes

1

Agreement for IVC minimum diameter (IVCmin)

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.

Time frame
Preoperative period, during the same imaging session.
2

Agreement for IVC diameter ratio (IVCmax:IVCmin)

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.

Time frame
Preoperative period, during the same imaging session.
3

Bland-Altman analysis for collapsibility index (cIVC)

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.

Time frame
Preoperative period, during the same imaging session.
4

Bland-Altman analysis for IVC maximum diameter

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.

Time frame
Preoperative period, during the same imaging session.

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