Femoral Venous Pulsatility and Right Heart Dysfunction in Heart Surgery: An Observational Study (FemousTechno6)

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.

Study Overview

• Status: Completed
• Conditions: Right Ventricular Dysfunction; Right Heart Failure; Heart; Dysfunction Postoperative, Cardiac Surgery

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Femous patients; Adults undergoing general anesthesia for an elective cardiac surgery requiring cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative complications will be defined as prolonged mechanical ventilation, inotropes or vasopressors dependencies, surgical second-look, acute kidney injury, mortality, hemorrhage, surgical sites infections, delirium and strokes	Immediate postoperative to Day 1 postoperatively at the intensive care unit
Compare right and left femoral vein Doppler's ultrasound		Before induction of anesthesia to day 1 postoperatively at the intensive care unit
Determine the most valid measure between long and short axis ultrasound of the femoral vein, and their respective sensibility and specificity to predict complications		Before induction of anesthesia to day 1 postoperatively at the intensive care unit
Determine the sensibility and specificity of the values obtained by the femoral vein Doppler ultrasound to predict postoperative complications		Before induction of anesthesia to day 1 postoperatively at the intensive care unit
Determine if the diameter of the femoral vein as a useful predictor of right heart failure or of post-operative complications		Before induction of anesthesia to day 1 postoperatively at the intensive care unit
Determine the association between an elevated femoral vein pulsatility and postoperative delirium (as evaluated by the Intensive Care Delirium Screening Checklist)		Before induction of anesthesia to day 1 postoperatively at the intensive care unit

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: August 28, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pulsatile Femoral Vein Doppler Flow
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: ICM # 2021-2963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No