Femoral Venous Pulsatility and Right Heart Dysfunction in Heart Surgery: An Observational Study

NCT05038267 | Completed

• 1 other identifier: ICM # 2021-2963
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Right heart failure during cardiac surgery is associated with increased perioperative morbidity and mortality. In this context, it is imperative to develop simple diagnostic tools to detect right heart failure. The purpose of this observational study is to determine if ultrasound Doppler of the femoral vein can detect and predict right ventricular failure after cardiac surgeries requiring cardiopulmonary bypass. It is expected that an elevated pulsatility of the femoral vein before the induction of general anesthesia is associated with perioperative right heart failure.

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery; Right Heart Failure; Right Ventricular Dysfunction

Keywords

Pulsatile Femoral Vein Doppler Flow

Outcome Measures

Primary Outcomes (1)

• Determine the prevalence of an elevated pulsatility of the femoral vein on Doppler ultrasound before the induction of general anesthesia

  An elevated pulsatility on Doppler ultrasound is defined as a biphasic signal of the femoral vein with a retrograde velocity \> 10 cm/s on a long axis view at an angle correction \< 60 degrees. If there's signs of cardiac modulation on the Doppler ultrasound, pulsatility index will be measured in long and short axis as followed : (maximal velocity - minimal velocity)/maximal velocity.

  Before induction of anesthesia to day 1 postoperatively at the intensive care unit

Secondary Outcomes (10)

• Determine the association between an elevated femoral vein pulsatility and diastolic or systolic right ventricular failure, before and after cardiac surgery and at the intensive care unit

  Before induction of anesthesia to day 1 postoperatively at the intensive care unit

• Determine the association between an elevated femoral vein pulsatility and the intracardiac pressures of the right heart cavities and the pulmonary artery

  Before induction of anesthesia to day 1 postoperatively at the intensive care unit

• Determine the association between the prevalence of an elevated femoral vein pulsatility and the portal vein pulsatility

  Before induction of anesthesia to day 1 postoperatively at the intensive care unit

• Determine the impact of positive-pressure ventilation on the femoral vein pulsatility

  After induction of anesthesia and before cardiopulmonary bypass.

• Determine the association between a preoperative elevated femoral vein pulsatility and postoperative complications.

  Immediate postoperative to Day 1 postoperatively at the intensive care unit

Study Arms (1)

Femous patients

Adults undergoing general anesthesia for an elective cardiac surgery requiring cardiopulmonary bypass

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

Adults undergoing elective cardiac surgery at the Montreal Heart Institute which requires cardiopulmonary bypass and perioperative trans oesophageal echography

You may qualify if:

• Adults (at least 18 years old)
• Able to consent
• Undergoing elective cardiac surgery at the Montreal Heart Institute
• Surgery requiring cardiopulmonary bypass
• Peri-operative trans-oesophageal echography planned

You may not qualify if:

• Critical preoperative state, defined as vasopressor requirement, mechanical support including intra-aortic balloon, mechanical ventilation or cardiac arrest necessitating resuscitation
• Know condition that could interfere with femoral venous assessment or interpretation (such as femoral vein thrombosis, femoral instrumentation, ECMO, etc.)
• Planned cardiac transplantation, implantation of a ventricular assist device or surgery for a congenital condition
• Pregnancy

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Olivier Lachance, MD: collaborator
• Melissa Parent, MD: collaborator
• Patrick Tawil, MD: collaborator
• Etienne Couture, MD PhD: collaborator
• William Beaubien Souligny, MD PhD: collaborator
• Yoan Lamarche, MD PhD: collaborator
• Alexander Calderone: collaborator
• Stephanie Jarry, MSc: collaborator
• Ali Hammoud, RN: collaborator
• Pierre Robillard, MD: collaborator
• Olivier Royer, MD: collaborator
• Elena Saade, MD: collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (3)

• Hammoud A, Mailhot T, Parent M, Huard K, Lachance O, Tawil P, Calderone A, Levesque S, Jarry S, Beaubien-Souligny W, Couture EJ, Denault AY. Femoral Vein Pulsatility and Neurocognitive Disorder in Cardiac Surgery. CJC Open. 2024 Nov 8;7(2):187-192. doi: 10.1016/j.cjco.2024.11.002. eCollection 2025 Feb.

  PMID: 40060204 DERIVED

• Huard K, Lachance O, Parent M, Tawil P, Saade E, Hammoud A, Couture EJ, Lamarche Y, Jarry S, Calderone A, Robillard P, Levesque S, Beaubien-Souligny W, Denault AY. Prevalence of abnormal common femoral vein pulsatility on Doppler ultrasound in patients undergoing cardiac surgery and its association with adverse events: a prospective cohort study. Can J Anaesth. 2025 Apr;72(4):615-626. doi: 10.1007/s12630-025-02911-9. Epub 2025 Mar 3.

  PMID: 40032766 DERIVED

• Couture EJ, Gronlykke L, Denault AY. New developments in the understanding of right ventricular function in acute care. Curr Opin Crit Care. 2022 Jun 1;28(3):331-339. doi: 10.1097/MCC.0000000000000946.

  PMID: 35653255 DERIVED

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FRCPC, ABIM-CCM

Study Record Dates

• First Submitted: August 28, 2021
• First Posted: September 9, 2021
• Study Start: August 30, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

CA (1)