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

NCT03052153 | Completed

• 1 other identifier: 2016H0435
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• All-cause mortality

  at 30 days post-transplant

• Hospital Length of Stay

  From hospital admission to discharge up to one year.

Study Arms (1)

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

Interventions

No investigational intervention performed for this study OTHER

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

Lung Transplant Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \. Patients ≤ 18 years of age

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Study Officials

• Amar Bhatt, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: January 7, 2017
• First Posted: February 14, 2017
• Study Start: March 17, 2017
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)