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Clinical Trials/NCT03052153
NCT03052153
Completed
Not Applicable

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

Ohio State University1 site in 1 country100 target enrollmentMarch 17, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Transplant Failure
Sponsor
Ohio State University
Enrollment
100
Locations
1
Primary Endpoint
incidence of graft dysfunction
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 17, 2017
End Date
February 4, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amar Bhatt

Attending Physician

Ohio State University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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

  • All-cause mortality(at 30 days post-transplant)
  • Hospital Length of Stay(From hospital admission to discharge up to one year.)

Study Sites (1)

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