Prediction of Pulmonary Graft Dysfunction After Double-lung Transplantation (PGD3-AI Study)

NCT04643665 | Completed

• 1 other identifier: 1111111111111
• Study Type: observational
• Target: 478
• Locations: 0 countries
• Sites: N/A

Brief Summary

The thundering evolution of lung transplantation management during the past ten years and primary graft dysfunction (PGD) new definition have led to new predictive factors of PGD. Therefore, we retrospectively analyzed a monocentric database using a machine-learning method, to determine the predictive factors of grade 3 PGD (PGD3), defined as a PaO2/FiO2 ratio \< 200 or being under extracorporeal membrane oxygenation (ECMO) at postoperative day 3. We included all double lung transplantation from 2012 to 2019 and excluded multi-organ transplant, cardiopulmonary bypass, or repeated transplantation during the study period for the same patient. Recipient, donor and intraoperative data were added in a gradient boosting algorithm step-by-step according to standard transplantation stages. Dataset will be split randomly as 80% training set and 20% testing set. Relationship between predictive factors and PGD3 will be represented as ShHapley Additive exPlanation (SHAP) values.

Conditions

Transplant Dysfunction; Transplantation, Lung

Outcome Measures

Primary Outcomes (1)

• risk factors for grade 3 pulmonary graft dysfunction at postoperative day 3

  PaO2/FiO2 ratio \< 200 or being under extracorporeal membrane oxygenation (ECMO) at postoperative day 3 due to hypoxemia

  3 days

Study Arms (2)

No grade 3 Pulmonary graft dysfunction at postoperative day 3

patients having not a grade 3 Pulmonary graft dysfunction at postoperative day 3

Procedure: Double-lung transplantation

Grade 3 Pulmonary graft dysfunction at postoperative day 3

patients having a grade 3 Pulmonary graft dysfunction at postoperative day 3

Procedure: Double-lung transplantation

Interventions

Double-lung transplantation PROCEDURE

Grade 3 Pulmonary graft dysfunction at postoperative day 3; No grade 3 Pulmonary graft dysfunction at postoperative day 3

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung transplanted patients

You may qualify if:

• double-lung transplantation

You may not qualify if:

• multi-organ transplant
• use of a cardiopulmonary bypass
• repeated transplantation during the study period for the same patient.

Sponsors & Collaborators

• Hopital Foch: lead

Study Officials

• Elisabeth Hulier Ammar, PhD

  Hopital Foch

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: January 1, 2012
• Primary Completion: December 31, 2019
• Study Completion: October 5, 2020
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share