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

19. November 2020 aktualisiert von: Hopital Foch

Prediction of Grade 3 Pulmonary Graft Dysfunction After Double-lung Transplantation From Donor, Recipient and Intraoperative Variables

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.

Studienübersicht

Status

Abgeschlossen

Detaillierte Beschreibung

The standardized anesthetic management has been previously described 18 and is detailed on the web site http://anesthesie-foch.org/protocoles-anesthesie/ ("The Foch lung transplant anesthesia protocol").

Continuous variables are presented as median + interquartile range (IQR) or mean and 95%CI, and were compared using independent T-test or Mann-Whitney test. Categorical variables are presented as n (%) and were compared using Chi-squared test or Fisher's exact test. We applied machine learning algorithm to predict 3-day ahead primary graft dysfunction after lung transplant surgery among patients. Machine learning is a branch of artificial intelligence where computer systems can learn from available data and identify patterns with minimal human intervention. Machine learning algorithm tests on data and performance metrics were used to obtain the higher performing algorithm. In this study, we performed a XGBoost (Gradient Boosting) algorithm which was a combination of decisions trees. Each decision tree typically learned from its precursor and passed on the improved function to the following. The weighted combination of these trees provided the prediction.

No particular data transformation has been performed on numerical variables. Categorical variables have been encoded as integer, without any further pre-processing steps. In particular, no specific processing has been performed to deal with missing data. The default behavior of XGBoost has been used. It consists in treating missing data as a specific modality. During the training step of XGBoost models, missing values are treated as other values, and left or right decisions at any branch of a tree are learned by optimizing the outcome.

In order to reflect the sequential nature of this predictive medicine problem, nine steps have been defined to take into account incrementally observed variables acquired at various stages of the surgery.

Step 1: recipient variables Step 2: donor variables Step 3: arrival in the OR Step 4: after anesthetic induction Step 5: during first pneumonectomy Step 6: after first graft implantation Step 7: second pneumonectomy Step 8: second graft implantation Step 9: end surgery status At each of the nine steps, a cross-validation procedure is employed to assess the predictive performance of a machine learning model (XGBoost). One repetition of the cross-validation procedure is designed as follows: the dataset of subjects is randomly split into eight disjoint parts. Successively, the performance of the XGBoost model on each of the eight subset,while training the machine learning model using the remaining seven subsets. For such a repetition, the predictive probability of 3-day ahead primary graft dysfunction for each subject is retained to finally compute the area under ROC (receiving operator curve). To evaluate the variability of the predictive performance of the machine learning model, this cross-validation procedure is repeated fifty times, with randomly chosen subjects partitions. For each of the fifty times eight times nine (repetitions, partitions, surgical steps), hence 3600 models training, a conservative approach has been adopted for XGBoost training, consisting in a unique set of training parameters. These parameters have been chosen to prevent overfitting due to a relatively small number of subjects compared to the number of variables, especially categorical variables, which yield a high degree of freedom. Specifically XGBoost has been trained for 400 rounds (no early stopping), a maximum depth of 5 for each tree, a minimum child weight of 3, and a learning parameter eta equals to 0.0002. Besides those conservative parameters chosen to prevent overfitting, only 40 percents of available columns are selected for tree construction at each round, and 95 % of subjects. These parameters have been kept fixed and chosen to ensure stability of results. Small perturbations around these values could result in local performance improvements, but would not be practically chosen given the size of the dataset.

In order to gain some insights into the most useful variables in terms of predictive power, we then conducted a post-hoc analysis based on the following methodology: at each surgical step, 400 models have been trained for the repeated cross-validation procedure. For each model, we retain the rank of each variable as given by the variable importance procedure of XGBoost. The average rank of each variable for each step is then computed by averaging the ranks obtained by variables for each of the 400 models. At step 9, variables are ordered based on their average rank (increasing average ranks). They are then incrementally used as input of a new cross-validation procedure (repeated 20 times).

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

478

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Lung transplanted patients

Beschreibung

Inclusion Criteria:

  • double-lung transplantation

Exclusion Criteria:

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
No grade 3 Pulmonary graft dysfunction at postoperative day 3
patients having not a grade 3 Pulmonary graft dysfunction at postoperative day 3
Grade 3 Pulmonary graft dysfunction at postoperative day 3
patients having a grade 3 Pulmonary graft dysfunction at postoperative day 3

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
risk factors for grade 3 pulmonary graft dysfunction at postoperative day 3
Zeitfenster: 3 days
PaO2/FiO2 ratio < 200 or being under extracorporeal membrane oxygenation (ECMO) at postoperative day 3 due to hypoxemia
3 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

  • Studienleiter: Elisabeth Hulier Ammar, PhD, Hopital Foch

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2012

Primärer Abschluss (Tatsächlich)

31. Dezember 2019

Studienabschluss (Tatsächlich)

5. Oktober 2020

Studienanmeldedaten

Zuerst eingereicht

19. November 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. November 2020

Zuerst gepostet (Tatsächlich)

25. November 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. November 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. November 2020

Zuletzt verifiziert

1. November 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 1111111111111

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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