Study Of Ultrasound Windows For Measuring Inferior Vena Cava Changes Before Cardiac Surgery
NCT ID: NCT07305051
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
283 participants
OBSERVATIONAL
2026-01-31
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jacobo Moreno Garijo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Science Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lilia Kaustov, MSC, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
McHorney CA, Tarlov AR. Individual-patient monitoring in clinical practice: are available health status surveys adequate? Qual Life Res. 1995 Aug;4(4):293-307. doi: 10.1007/BF01593882.
Whiting PF, Rutjes AW, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, Leeflang MM, Sterne JA, Bossuyt PM; QUADAS-2 Group. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. 2011 Oct 18;155(8):529-36. doi: 10.7326/0003-4819-155-8-201110180-00009.
Blehar DJ, Barton B, Gaspari RJ. Learning curves in emergency ultrasound education. Acad Emerg Med. 2015 May;22(5):574-82. doi: 10.1111/acem.12653. Epub 2015 Apr 22.
Spencer KT, Kimura BJ, Korcarz CE, Pellikka PA, Rahko PS, Siegel RJ. Focused cardiac ultrasound: recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr. 2013 Jun;26(6):567-81. doi: 10.1016/j.echo.2013.04.001. No abstract available.
Sites BD, Spence BC, Gallagher JD, Wiley CW, Bertrand ML, Blike GT. Characterizing novice behavior associated with learning ultrasound-guided peripheral regional anesthesia. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):107-15. doi: 10.1016/j.rapm.2006.11.006.
Croskerry P. The importance of cognitive errors in diagnosis and strategies to minimize them. Acad Med. 2003 Aug;78(8):775-80. doi: 10.1097/00001888-200308000-00003.
Sanfilippo F, La Via L, Dezio V, Santonocito C, Amelio P, Genoese G, Astuto M, Noto A. Assessment of the inferior vena cava collapsibility from subcostal and trans-hepatic imaging using both M-mode or artificial intelligence: a prospective study on healthy volunteers. Intensive Care Med Exp. 2023 Apr 3;11(1):15. doi: 10.1186/s40635-023-00505-7.
Sanfilippo F, La Via L, Dezio V, Amelio P, Genoese G, Franchi F, Messina A, Robba C, Noto A. Inferior vena cava distensibility from subcostal and trans-hepatic imaging using both M-mode or artificial intelligence: a prospective study on mechanically ventilated patients. Intensive Care Med Exp. 2023 Jul 10;11(1):40. doi: 10.1186/s40635-023-00529-z.
Hasanin A, Karam N, Mostafa M, Abdelnasser A, Hamimy W, Fouad AZ, Eladawy A, Lotfy A. THE ACCURACY OF INFERIOR VENA CAVA DISTENSIBILITY THROUGH THE TRANSHEPATIC APPROACH TO PREDICT FLUID RESPONSIVENESS IN PATIENTS WITH SEPTIC SHOCK AFTER EMERGENCY LAPAROTOMY. Shock. 2023 Oct 1;60(4):560-564. doi: 10.1097/SHK.0000000000002212. Epub 2023 Aug 23.
Bortolotti P, Colling D, Colas V, Voisin B, Dewavrin F, Poissy J, Girardie P, Kyheng M, Saulnier F, Favory R, Preau S. Respiratory changes of the inferior vena cava diameter predict fluid responsiveness in spontaneously breathing patients with cardiac arrhythmias. Ann Intensive Care. 2018 Aug 2;8(1):79. doi: 10.1186/s13613-018-0427-1.
Manzur-Sandoval D, Arteaga-Cardenas G, Gopar-Nieto R, Lazcano-Diaz E, Rojas-Velasco G. Correlation between transhepatic and subcostal inferior vena cava ultrasonographic images for evaluating fluid responsiveness after cardiac surgery. J Card Surg. 2022 Sep;37(9):2586-2591. doi: 10.1111/jocs.16696. Epub 2022 Jun 23.
Kelly N, Esteve R, Papadimos TJ, Sharpe RP, Keeney SA, DeQuevedo R, Portner M, Bahner DP, Stawicki SP. Clinician-performed ultrasound in hemodynamic and cardiac assessment: a synopsis of current indications and limitations. Eur J Trauma Emerg Surg. 2015 Oct;41(5):469-80. doi: 10.1007/s00068-014-0492-6. Epub 2015 Jan 8.
de Oliveira OH, Freitas FG, Ladeira RT, Fischer CH, Bafi AT, Azevedo LC, Machado FR. Comparison between respiratory changes in the inferior vena cava diameter and pulse pressure variation to predict fluid responsiveness in postoperative patients. J Crit Care. 2016 Aug;34:46-9. doi: 10.1016/j.jcrc.2016.03.017. Epub 2016 Mar 30.
Garijo JM, Wijeysundera DN, Munro JC, Meineri M. Correlation Between Transhepatic and Subcostal Inferior Vena Cava Views to Assess Inferior Vena Cava Variation: A Pilot Study. J Cardiothorac Vasc Anesth. 2017 Jun;31(3):973-979. doi: 10.1053/j.jvca.2017.02.003. Epub 2017 Feb 3.
Kulkarni AP, Janarthanan S, Harish MM, Suhail S, Chaudhari H, Agarwal V, Patil VP, Divatia JV. Agreement between inferior vena cava diameter measurements by subxiphoid versus transhepatic views. Indian J Crit Care Med. 2015 Dec;19(12):719-22. doi: 10.4103/0972-5229.171390.
Haroun F, Robinson M, Shayman CS, Cotton J. Subcostal versus right lateral ultrasound measurements of inferior vena cava: Measurements obtained from these two views are not equivalent in non-ICU patients. Ultrasound. 2023 Aug;31(3):196-203. doi: 10.1177/1742271X221124901. Epub 2022 Nov 16.
Ghosh S, Padhi R, Sahu S, Meher M, Jain P, Subudhi SK, Vihari J, Samal A, Sahu AK. Use of inferior vena cava guided fluid therapy in the treatment of septic shock: A randomised controlled trial. J Infect Dev Ctries. 2024 Jan 31;18(1):75-81. doi: 10.3855/jidc.18489.
Pour-Ghaz I, Manolukas T, Foray N, Raja J, Rawal A, Ibebuogu UN, Khouzam RN. Accuracy of non-invasive and minimally invasive hemodynamic monitoring: where do we stand? Ann Transl Med. 2019 Sep;7(17):421. doi: 10.21037/atm.2019.07.06.
Preau S, Bortolotti P, Colling D, Dewavrin F, Colas V, Voisin B, Onimus T, Drumez E, Durocher A, Redheuil A, Saulnier F. Diagnostic Accuracy of the Inferior Vena Cava Collapsibility to Predict Fluid Responsiveness in Spontaneously Breathing Patients With Sepsis and Acute Circulatory Failure. Crit Care Med. 2017 Mar;45(3):e290-e297. doi: 10.1097/CCM.0000000000002090.
Airapetian N, Maizel J, Alyamani O, Mahjoub Y, Lorne E, Levrard M, Ammenouche N, Seydi A, Tinturier F, Lobjoie E, Dupont H, Slama M. Does inferior vena cava respiratory variability predict fluid responsiveness in spontaneously breathing patients? Crit Care. 2015 Nov 13;19:400. doi: 10.1186/s13054-015-1100-9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6762
Identifier Type: -
Identifier Source: org_study_id