NCT05993377

Brief Summary

The investigators are planning to perform a secondary analysis of an academic dataset of 1,303 patients with moderate-to-severe acute respiratory distress syndrome (ARDS) included in several published cohorts (NCT00736892, NCT022288949, NCT02836444, NCT03145974), aimed to characterize the best early scenario during the first three days of diagnosis to predict duration of mechanical ventilation in the intensive care unit (ICU) using supervised machine learning (ML) approaches.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,303

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
2 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

August 14, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2024

Completed
Last Updated

March 20, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

August 4, 2023

Last Update Submit

March 19, 2024

Conditions

Keywords

mechanical ventilationintensive care unitduration of ventilationmachine learning.

Outcome Measures

Primary Outcomes (1)

  • Days on mechanical ventilation

    Duration of mechanical ventilation

    from diagnosis to extubation

Secondary Outcomes (1)

  • ICU mortality

    up to 24 weeks

Study Arms (2)

Derivation and testing cohort

It will contain 1000 ARDS patients

Other: Logistic regression Cross validation Area under the RIC curves Machine learning analysis. .

Confirmatory cohort

It will contain 303 patients (for external validation)

Other: Logistic regression Cross validation Area under the RIC curves Machine learning analysis. .

Interventions

we will use robust machine learning approaches, such as Random Forest and XGBoost.

Confirmatory cohortDerivation and testing cohort

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

De-identified dataset including 1,303 patients with moderate/severe ARDS admitted consecutively in a network of Spanish ICUs.

You may qualify if:

  • Berlin criteria for moderate to severe acute respiratory distress syndrome

You may not qualify if:

  • Postoperative patients ventilated \<24h
  • brain death patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Hospital Universitario Dr. Negrin

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

Location

Hospital Universitario Puerta de Hierro (ICU)

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario NS de Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Location

Hospital NS del Prado

Talavera de la Reina, Toledo, Spain

Location

Hospital Universitario de A Coruña (ICU)

A Coruña, 15006, Spain

Location

Complejo Hospitalario Universitario de Albacete (ICU)

Albacete, 02006, Spain

Location

Complejo Hospitalario de Albacete

Albacete, Spain

Location

Department of Anesthesia, Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital General de Ciudad Real (ICU)

Ciudad Real, 13005, Spain

Location

Hospital Virgen de La Luz

Cuenca, Spain

Location

Complejo Hospitalario Universitario de León

León, Spain

Location

Hospital Universitario Ramón y Cajal (Anesthesia)

Madrid, 28034, Spain

Location

Hospital Universitario La Paz (ICU)

Madrid, 28046, Spain

Location

Hospital Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Universitario Regional de Malaga Carlos Haya (ICU)

Málaga, 29010, Spain

Location

Hospital Universitario Carlos Haya

Málaga, Spain

Location

Hospital Universitario Virgen de Arrixaca (ICU)

Murcia, 30120, Spain

Location

Hospital Universitario Río Hortega (ICU)

Valladolid, 47012, Spain

Location

Hospital Virgen de la Concha (ICU)

Zamora, 49022, Spain

Location

Cardiff University

Cardiff, United Kingdom

Location

Related Publications (3)

  • Villar J, Ambros A, Mosteiro F, Martinez D, Fernandez L, Ferrando C, Carriedo D, Soler JA, Parrilla D, Hernandez M, Andaluz-Ojeda D, Anon JM, Vidal A, Gonzalez-Higueras E, Martin-Rodriguez C, Diaz-Lamas AM, Blanco J, Belda J, Diaz-Dominguez FJ, Rico-Feijoo J, Martin-Delgado C, Romera MA, Gonzalez-Martin JM, Fernandez RL, Kacmarek RM; Spanish Initiative for Epidemiology, Stratification and Therapies of ARDS (SIESTA) Network. A Prognostic Enrichment Strategy for Selection of Patients With Acute Respiratory Distress Syndrome in Clinical Trials. Crit Care Med. 2019 Mar;47(3):377-385. doi: 10.1097/CCM.0000000000003624.

  • Figueroa-Casas JB, Dwivedi AK, Connery SM, Quansah R, Ellerbrook L, Galvis J. Predictive models of prolonged mechanical ventilation yield moderate accuracy. J Crit Care. 2015 Jun;30(3):502-5. doi: 10.1016/j.jcrc.2015.01.020. Epub 2015 Jan 30.

  • Villar J, Gonzalez-Martin JM, Fernandez C, Soler JA, Ambros A, Pita-Garcia L, Fernandez L, Ferrando C, Arocas B, Gonzalez-Vaquero M, Anon JM, Gonzalez-Higueras E, Parrilla D, Vidal A, Fernandez MM, Rodriguez-Suarez P, Fernandez RL, Gomez-Bentolila E, Burns KEA, Szakmany T, Steyerberg EW, The PredictION Of Duration Of mEchanical vEntilation In Ards Pioneer Network. Predicting the Length of Mechanical Ventilation in Acute Respiratory Disease Syndrome Using Machine Learning: The PIONEER Study. J Clin Med. 2024 Mar 21;13(6):1811. doi: 10.3390/jcm13061811.

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Jesús Villar

    Hospital Universitario D. Negrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 15, 2023

Study Start

August 14, 2023

Primary Completion

February 2, 2024

Study Completion

February 2, 2024

Last Updated

March 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations