Clinical trial NCT05038267: Femoral Venous Pulsatility and Right Heart Dysfunction in Heart Surgery: An Observational Study
Official title: Femoral Venous Pulsatility and Right Heart Dysfunction in Heart Surgery: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
Right Heart Failure
Right Ventricular Dysfunction
Keywords: Pulsatile Femoral Vein Doppler Flow
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Olivier Lachance, MD
name: Melissa Parent, MD
name: Patrick Tawil, MD
name: Etienne Couture, MD PhD
name: William Beaubien Souligny, MD PhD
name: Yoan Lamarche, MD PhD
name: Alexander Calderone
name: Stephanie Jarry, MSc
name: Ali Hammoud, RN
name: Pierre Robillard, MD
name: Olivier Royer, MD
name: Elena Saade, MD
First posted: 2021-09-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Determine the prevalence of an elevated pulsatility of the femoral vein on Doppler ultrasound before the induction of general anesthesia
timeFrame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
Secondary outcomes:
measure: 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
timeFrame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
measure: Determine the association between an elevated femoral vein pulsatility and the intracardiac pressures of the right heart cavities and the pulmonary artery
timeFrame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
measure: Determine the association between the prevalence of an elevated femoral vein pulsatility and the portal vein pulsatility
timeFrame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
measure: Determine the impact of positive-pressure ventilation on the femoral vein pulsatility
timeFrame: After induction of anesthesia and before cardiopulmonary bypass.
measure: Determine the association between a preoperative elevated femoral vein pulsatility and postoperative complications.
timeFrame: Immediate postoperative to Day 1 postoperatively at the intensive care unit
measure: Compare right and left femoral vein Doppler's ultrasound
timeFrame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
measure: Determine the most valid measure between long and short axis ultrasound of the femoral vein, and their respective sensibility and specificity to predict complications
timeFrame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
measure: Determine the sensibility and specificity of the values obtained by the femoral vein Doppler ultrasound to predict postoperative complications
timeFrame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
measure: Determine if the diameter of the femoral vein as a useful predictor of right heart failure or of post-operative complications
timeFrame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
measure: Determine the association between an elevated femoral vein pulsatility and postoperative delirium (as evaluated by the Intensive Care Delirium Screening Checklist)
timeFrame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
References:
citation: 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.