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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05038267
Acronym
FemousTechno6
Enrollment
150
Registered
2021-09-09
Start date
2021-08-30
Completion date
2023-08-30
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pulsatile Femoral Vein Doppler Flow

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determine the prevalence of an elevated pulsatility of the femoral vein on Doppler ultrasound before the induction of general anesthesiaBefore induction of anesthesia to day 1 postoperatively at the intensive care unitAn 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

MeasureTime frameDescription
Determine the association between an elevated femoral vein pulsatility and the intracardiac pressures of the right heart cavities and the pulmonary arteryBefore 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 pulsatilityBefore induction of anesthesia to day 1 postoperatively at the intensive care unit
Determine the impact of positive-pressure ventilation on the femoral vein pulsatilityAfter 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 unitPostoperative 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
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 unitBefore 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 complicationsBefore 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 complicationsBefore 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 complicationsBefore 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
Compare right and left femoral vein Doppler's ultrasoundBefore induction of anesthesia to day 1 postoperatively at the intensive care unit

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026