Heart; Dysfunction Postoperative, Cardiac SurgeryFemousTechno6NCT05038267
Femoral Venous Pulsatility and Right Heart Dysfunction in Heart Surgery: An Observational Study
An observational study of Heart; Dysfunction Postoperative, Cardiac Surgery and Right Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Dysfunction Postoperative, Cardiac Surgery, Right Heart Failure, Right Ventricular Dysfunction
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 30 Aug 2021to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing elective cardiac surgery at the Montreal Heart Institute which requires cardiopulmonary bypass and perioperative trans oesophageal echography
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heart; Dysfunction Postoperative, Cardiac Surgery, Right Heart Failure, Right Ventricular Dysfunction
- Keywords
- Pulsatile Femoral Vein Doppler Flow
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Femous patients | Adults undergoing general anesthesia for an elective cardiac surgery requiring cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
Secondary outcomes (10)
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
Measured: 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
Measured: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
Determine the association between the prevalence of an elevated femoral vein pulsatility and the portal vein pulsatility
Measured: 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
Measured: After induction of anesthesia and before cardiopulmonary bypass.
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
Measured: Immediate postoperative to Day 1 postoperatively at the intensive care unit
Compare right and left femoral vein Doppler's ultrasound
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start30 Aug 2021
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart; Dysfunction Postoperative, Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Andre Denault, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038267
- Sponsor's protocol ID
- ICM # 2021-2963
- Acronym
- FemousTechno6
- Status last verified
- Mar 2024
- First submitted
- 28 Aug 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hammoud A, Mailhot T, Parent M, Huard K, Lachance O, Tawil P, Calderone A, Levesque S, Jarry S, Beaubien-Souligny W, Couture EJ, Denault AY. Femoral Vein Pulsatility and Neurocognitive Disorder in Cardiac Surgery. CJC Open. 2024 Nov 8;7(2):187-192. doi: 10.1016/j.cjco.2024.11.002. eCollection 2025 Feb.
PubMed 40060204Huard K, Lachance O, Parent M, Tawil P, Saade E, Hammoud A, Couture EJ, Lamarche Y, Jarry S, Calderone A, Robillard P, Levesque S, Beaubien-Souligny W, Denault AY. Prevalence of abnormal common femoral vein pulsatility on Doppler ultrasound in patients undergoing cardiac surgery and its association with adverse events: a prospective cohort study. Can J Anaesth. 2025 Apr;72(4):615-626. doi: 10.1007/s12630-025-02911-9. Epub 2025 Mar 3.
PubMed 40032766Couture 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Venous Pulsatility and Right Heart Dysfunction in Heart Surgery: An Observational Study
- ClinicalTrials.gov ID
- NCT05038267
- Acronym / sponsor ID
- FemousTechno6 / ICM # 2021-2963
- Conditions
- Heart; Dysfunction Postoperative, Cardiac Surgery, Right Heart Failure, Right Ventricular Dysfunction
- Keywords
- Pulsatile Femoral Vein Doppler Flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- 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
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femous patients | – | –Adults undergoing general anesthesia for an elective cardiac surgery requiring cardiopulmonary bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing elective cardiac surgery at the Montreal Heart Institute which requires cardiopulmonary bypass and perioperative trans oesophageal echography
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the prevalence of an elevated pulsatility of the femoral vein on Doppler ultrasound before the induction of general anesthesia
Time frame: 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.
10 secondary outcomes
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
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
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
Determine the impact of positive-pressure ventilation on the femoral vein pulsatility
Time frame: After induction of anesthesia and before cardiopulmonary bypass.
Determine the association between a preoperative elevated femoral vein pulsatility and postoperative complications.
Time frame: Immediate postoperative to Day 1 postoperatively at the intensive care unit
Compare right and left femoral vein Doppler's ultrasound
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 40060204Hammoud A, Mailhot T, Parent M, Huard K, Lachance O, Tawil P, Calderone A, Levesque S, Jarry S, Beaubien-Souligny W, Couture EJ, Denault AY. Femoral Vein Pulsatility and Neurocognitive Disorder in Cardiac Surgery. CJC Open. 2024 Nov 8;7(2):187-192. doi: 10.1016/j.cjco.2024.11.002. eCollection 2025 Feb.
- Derived from this study: PubMed 40032766Huard K, Lachance O, Parent M, Tawil P, Saade E, Hammoud A, Couture EJ, Lamarche Y, Jarry S, Calderone A, Robillard P, Levesque S, Beaubien-Souligny W, Denault AY. Prevalence of abnormal common femoral vein pulsatility on Doppler ultrasound in patients undergoing cardiac surgery and its association with adverse events: a prospective cohort study. Can J Anaesth. 2025 Apr;72(4):615-626. doi: 10.1007/s12630-025-02911-9. Epub 2025 Mar 3.
- Derived from this study: PubMed 35653255Couture 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart; Dysfunction Postoperative, Cardiac Surgery and Right Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the prevalence of an elevated pulsatility of the femoral vein on Doppler ultrasound before the induction of general anesthesia (time frame: Before induction of anesthesia to day 1 postoperatively at the intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05038267, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.