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CompletedNCT05038267FemousTechno6Updated Mar 19, 2024

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

An observational study in Heart; Dysfunction Postoperative, Cardiac Surgery, Right Heart Failure and Right Ventricular Dysfunction, sponsored by Montreal Heart Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Montreal Heart Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Heart Failure by Montreal Heart Institute — 4 open to participants now, 4 under way, none of them phase 3. Heart Failure · Montreal Heart Institute.

Started
2021
with 2 others
Observational
6 of 22
1 open now
Registered
19th of 22
by date

Among the 22 studies in Heart Failure by Montreal Heart Institute, this one is one of 3 that started in 2021, is one of 6 observational ones, and was the 19th registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

No phase8 · 2 open
Observationalthis study6 · 1 open
Phase 44 · 0 open
Phase 22 · 1 open
Other kind1 · 0 open
Phase 31 · 0 open

By the year they started

First in 2001; this study’s year is marked. 3 started in 2021.

Size and results

Median enrollment 120 across the 15 interventional studies, 146 across the 7 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 22 studies in Heart Failure by Montreal Heart Institute, or all of them as a file.
02

Study 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.

03

Conditions studied

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

Keywords

  • Pulsatile Femoral Vein Doppler Flow
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • Femous patients

    Adults undergoing general anesthesia for an elective cardiac surgery requiring cardiopulmonary bypass

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit

Secondary outcomes

  1. 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

    Time frame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit

  2. Determine the association between an elevated femoral vein pulsatility and the intracardiac pressures of the right heart cavities and the pulmonary artery

    Time frame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit

  3. Determine the association between the prevalence of an elevated femoral vein pulsatility and the portal vein pulsatility

    Time frame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit

  4. Determine the impact of positive-pressure ventilation on the femoral vein pulsatility

    Time frame: After induction of anesthesia and before cardiopulmonary bypass.

  5. 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

    Time frame: Immediate postoperative to Day 1 postoperatively at the intensive care unit

  6. Compare right and left femoral vein Doppler's ultrasound

    Time frame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit

  7. Determine the most valid measure between long and short axis ultrasound of the femoral vein, and their respective sensibility and specificity to predict complications

    Time frame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit

  8. Determine the sensibility and specificity of the values obtained by the femoral vein Doppler ultrasound to predict postoperative complications

    Time frame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit

  9. Determine if the diameter of the femoral vein as a useful predictor of right heart failure or of post-operative complications

    Time frame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit

  10. Determine the association between an elevated femoral vein pulsatility and postoperative delirium (as evaluated by the Intensive Care Delirium Screening Checklist)

    Time frame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit

07

Study locations

1 site
  • Montreal Heart Institute
    Montreal, Quebec H1T 1C8, Canada
08

References and documents

Publications

  • 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. PubMed 35653255 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05038267
Collaborators
Olivier Lachance, MD, Melissa Parent, MD, Patrick Tawil, MD, Etienne Couture, MD PhD, William Beaubien Souligny, MD PhD, Yoan Lamarche, MD PhD, Alexander Calderone, Stephanie Jarry, MSc, Ali Hammoud, RN, Pierre Robillard, MD, Olivier Royer, MD, Elena Saade, MD
Responsible party
Andre Denault (MD, PhD, FRCPC, ABIM-CCM, Montreal Heart Institute) — Principal investigator
First posted
Sep 9, 2021
Start date
Aug 30, 2021
Primary completion
Aug 30, 2023
Completion
Aug 30, 2023
Last update
Mar 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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