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

Right Ventricular Dysfunction Clinical Trial

— FemousTechno6  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05038267
• Other study ID #: ICM # 2021-2963
• Status: Completed
• Start date: August 30, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: March 2024
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (13)

Lead Sponsor	Collaborator
Montreal Heart Institute	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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Determine the impact of positive-pressure ventilation on the femoral vein pulsatility		After induction of anesthesia and before cardiopulmonary bypass.
Secondary	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
Secondary	Compare right and left femoral vein Doppler's ultrasound		Before induction of anesthesia to day 1 postoperatively at the intensive care unit
Secondary	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
Secondary	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
Secondary	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
Secondary	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