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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03052153

Enrollment

100

Registered

2017-02-14

Start date

2017-03-17

Completion date

2021-02-04

Last updated

2021-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplant Failure

Brief summary

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.

Detailed description

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.

Interventions

OTHERNo investigational intervention performed for this study

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

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. All adult patients ≥ 18 years of age 2. 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

1\. Patients ≤ 18 years of age

Design outcomes

Primary

Measure	Time frame	Description
incidence of graft dysfunction	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).
grade of graft dysfunction	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

Measure	Time frame	Description
All-cause mortality	at 30 days post-transplant	To measure and report all-cause mortality at 30 days post-transplant.
Hospital Length of Stay	From hospital admission to discharge up to one year.	To report subjects hospital length of stay for up to one year.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026