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Completed

NCT Number: NCT03052153

Intraoperative Echocardiographic Evaluation of Pulmonary Vein Velocities and Outcomes in Lung Transplantation

This study will evaluate if an association exists between levels of blood flow through the pulmonary veins and the incidence of graft dysfunction post operatively.

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Key information

Conditions

Lung Transplant Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

Lung transplantation surgery can be fraught with a multitude of early as well as delayed complications leading to increased morbidity and mortality. During lung transplant surgery, trans-esophageal echocardiography (TEE) is routinely used to identify cardiac anatomy and measure blood flow through the pulmonary veins. This blood flow is assessed both before and after the lung has been transplanted. Blood flow through these small caliber vessels can be impacted by many variables with a resulting reduction in blood circulating to the lung, although currently there is no agreement on an acceptable level of flow. This study will look at retrospective data from lung transplant surgeries undertaken at this institution since Jan 1st 2014 until November 18th 2016 with the goal of determining if an association exists between levels of blood flow through the pulmonary veins and the incidence of graft dysfunction post operatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adult patients ≥ 18 years of age
  • Having undergone single or bilateral lung transplantation surgery at Ohio State University Wexner Medical Center between January 1st 2014 and November 18th 2016

Exclusion criteria

  • Patients ≤ 18 years of age

Treatment and study plan

No investigational intervention performed for this study

Other

No investigational intervention for the purpose of this study was performed; data collected is retrospective data previously collected for non-research purposes.

Primary outcomes

  1. incidence of graft dysfunction

    Time frame: at 30 days post-transplant

    To describe the relationship between intra-operative pulmonary vein systolic velocities and the incidence of graft dysfunction as defined by the International Society for Heart and Lung Transplantation (ISHLT).

  2. grade of graft dysfunction

    Time frame: at 30 days post-transplant

    To describe the relationship between intra-operative pulmonary vein systolic velocities and grade of graft dysfunction as defined by the International Society for Heart and Lung Transplantation (ISHLT).

Secondary outcomes

  1. All-cause mortality

    Time frame: at 30 days post-transplant

    To measure and report all-cause mortality at 30 days post-transplant.

  2. Hospital Length of Stay

    Time frame: From hospital admission to discharge up to one year.

    To report subjects hospital length of stay for up to one year.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 14, 2017
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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