Skip to main content
OpenTrials
Completed

NCT Number: NCT05038267

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

    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.

Secondary outcomes

  1. 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

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

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

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

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

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

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

    Time frame: After induction of anesthesia and before cardiopulmonary bypass.

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

    Time frame: Immediate postoperative to Day 1 postoperatively at the intensive care unit

    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

  6. Compare right and left femoral vein Doppler's ultrasound

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

  7. Determine the most valid measure between long and short axis ultrasound of the femoral vein, and their respective sensibility and specificity to predict complications

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

  8. Determine the sensibility and specificity of the values obtained by the femoral vein Doppler ultrasound to predict postoperative complications

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

  9. Determine if the diameter of the femoral vein as a useful predictor of right heart failure or of post-operative complications

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

  10. Determine the association between an elevated femoral vein pulsatility and postoperative delirium (as evaluated by the Intensive Care Delirium Screening Checklist)

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

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

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

Registry information

Acronym: FemousTechno6

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2021
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.