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

Completed

• Conditions: Lung Transplant Failure
• Interventions: Other: No investigational intervention performed for this study

• Registration Number: NCT03052153
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study First Submitted: 2017-01-07
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Study Start: 2017-03-17
• Primary Completion: 2021-02-04
• Study Completion: 2021-02-04
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung Transplant Surgery	No investigational intervention performed for this study	Subjects included in the study will have undergone a single or bilateral lung transplant surgery at The Ohio State University Wexner Medical Center between 01 JAN 2014 and 18 NOV 2016. No investigational intervention performed for this study.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States