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

NCT07305051 | Not Yet Recruiting

• 1 other identifier: 6762
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perioperative Fluid Management; Hemodynamic Monitoring; Inferior Vena Cava Collapsibility Index; Cardiac Surgery Patients

Keywords

point-of-care ultrasound (POCUS); Transhepatic view; Subcostal view; Inferior vena cava (IVC); Echocardiography; Ultrasound imaging; Central venous assessment; Cardiac surgery; Fluid status assessment; Interrater reliability; Sunnybrook Health Sciences Centre; Adult patients

Outcome Measures

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.

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

Secondary Outcomes (3)

• Inter-rater reliability for transhepatic collapsibility index (cIVC)

  Preoperative period, during the same imaging session.

• Agreement for IVC maximum diameter (IVCmax)

  Preoperative period, during the same imaging session.

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

  Preoperative period, during the same imaging session.

Other Outcomes (5)

• Agreement for IVC minimum diameter (IVCmin)

  Preoperative period, during the same imaging session.

• Agreement for IVC diameter ratio (IVCmax:IVCmin)

  Preoperative period, during the same imaging session.

• Bland-Altman analysis for collapsibility index (cIVC)

  Preoperative period, during the same imaging session.

Study Arms (1)

Adult Cardiac Surgery Patients

This group includes adult patients (Age ≥ 18) who are awake, spontaneously breathing, and scheduled to undergo cardiac surgery at Sunnybrook Health Sciences Centre. They must also be able to lie supine and provide informed consent.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location

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Study Officials

• Jacobo Moreno Garijo, MD, PhD

  Sunnybrook Health Science Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilia Kaustov, MSc, PhD

CONTACT

416-967-8587; Lilia.Kaustov@sunnybrook.ca

Ignacio Erbetta, MD

CONTACT

416-967-8587; ignacio.erbetta@sri.utoronto.ca

Study Design

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

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: De-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, and analytic code) will be made available beginning 12 months after publication of the primary manuscript. Data will remain available for a minimum of 5 years following publication, through secure institutional servers at Sunnybrook Research Institute. Access will be granted to qualified researchers upon reasonable request to the Principal Investigator, subject to a data sharing agreement that ensures privacy and appropriate use.
• Access Criteria: De-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, and analytic code) will be accessible to qualified researchers affiliated with academic or healthcare institutions. Requests must include a brief research proposal outlining objectives, methods, and intended use of the data. Access will be granted upon approval by the Principal Investigator and execution of a data-sharing agreement that ensures compliance with privacy, confidentiality, and ethical use standards. Approved researchers will receive access to the data through secure institutional servers at Sunnybrook Research Institute.

Locations

CA (1)