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

NCT ID: NCT05038267

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-30

Study Completion Date

2023-08-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Femous patients

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olivier Lachance, MD

UNKNOWN

Sponsor Role collaborator

Melissa Parent, MD

UNKNOWN

Sponsor Role collaborator

Patrick Tawil, MD

UNKNOWN

Sponsor Role collaborator

Etienne Couture, MD PhD

UNKNOWN

Sponsor Role collaborator

William Beaubien Souligny, MD PhD

UNKNOWN

Sponsor Role collaborator

Yoan Lamarche, MD PhD

UNKNOWN

Sponsor Role collaborator

Alexander Calderone

UNKNOWN

Sponsor Role collaborator

Stephanie Jarry, MSc

UNKNOWN

Sponsor Role collaborator

Ali Hammoud, RN

UNKNOWN

Sponsor Role collaborator

Pierre Robillard, MD

UNKNOWN

Sponsor Role collaborator

Olivier Royer, MD

UNKNOWN

Sponsor Role collaborator

Elena Saade, MD

UNKNOWN

Sponsor Role collaborator

Montreal Heart Institute

OTHER

Sponsor Role lead

Responsible Party

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Andre Denault

MD, PhD, FRCPC, ABIM-CCM

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 40060204 (View on PubMed)

Huard 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.

Reference Type DERIVED
PMID: 40032766 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35653255 (View on PubMed)

Other Identifiers

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ICM # 2021-2963

Identifier Type: -

Identifier Source: org_study_id

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