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

Completed

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

• Registration Number: NCT05038267
• Lead Sponsor: Montreal Heart Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-28
• Study Start: 2021-08-30
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-09
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the prevalence of an elevated pulsatility of the femoral vein on Doppler ultrasound before the induction of general anesthesia	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 Outcome Measures

Name	Time	Method
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 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 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 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 the impact of positive-pressure ventilation on the femoral vein pulsatility	After induction of anesthesia and before cardiopulmonary bypass.
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 association between a preoperative elevated femoral vein pulsatility and postoperative complications.	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
Compare right and left femoral vein Doppler's ultrasound	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
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

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada