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

Lung Transplant Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052153
• Other study ID #: 2016H0435
• Status: Completed
• Start date: March 17, 2017
• Est. completion date: February 4, 2021

Study information

• Verified date: September 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 4, 2021
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant Failure

Intervention

Other:
• No 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.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of graft dysfunction	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).	at 30 days post-transplant
Primary	grade of graft dysfunction	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).	at 30 days post-transplant
Secondary	All-cause mortality	To measure and report all-cause mortality at 30 days post-transplant.	at 30 days post-transplant
Secondary	Hospital Length of Stay	To report subjects hospital length of stay for up to one year.	From hospital admission to discharge up to one year.