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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05038267
Other study ID # ICM # 2021-2963
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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