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.

Study Overview

• Status: Completed
• Conditions: Lung Transplant Failure
• Intervention / Treatment: Other: No investigational intervention performed for this study

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include all surgical patients 18 years of age and older who underwent single or bilateral lung transplantation surgery during the period January 1st 2014 to November 18 2016 at Ohio State University Wexner Medical Center. Database screening for patient inclusion in retrospective analysis will be performed by designated personnel from the Anesthesiology Department or co-investigators entitled to work with patients' electronic data.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung Transplant Surgery; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	To measure and report all-cause mortality at 30 days post-transplant.	at 30 days post-transplant
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.

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Amar Bhatt, MD, The Ohio State University Wexner Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Actual): February 4, 2021
• Study Completion (Actual): February 4, 2021

Study Registration Dates

• First Submitted: January 7, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2016H0435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No