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Global BurdEn of MechanIcal VeNtilatIon (GEMINI). VeNtilatIon (GEMINI Study) 2022 for VENTILAGROUP.

NCT05392010 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10900

Last updated 2024-02-28

No results posted yet for this study

Summary

BACKGROUND: Changes in the clinical practice of mechanical ventilation during and after the coronavirus pandemic (COVID-19) worldwide could influence the clinical outcomes of critically ill patients with mechanical ventilation due to a generalization of these changes. Thus, the variability of the clinical response of different strategies in critically ill patients could be related to the existence of unidentified phenotypes that would be related to an increased risk of mortality and functional deterioration at the medium term.

OBJECTIVES: The main objective will be to evaluate the worldwide clinical practice of mechanical Ventilation in critically ill patients, as well as the medium-term clinical outcomes for the description of phenotypes of critically ill patients treated with mechanical ventilation.

The analysis of phenotypes and unsupervised pattern recognition over time could help to predict relevant clinical outcomes. This approach could improve personalized and precision medicine applicable to the ventilated patient. METHODOLOGY: An observational, prospective, non-interventional, international, and multicenter study will be carried out that will include adult critically ill patients requiring invasive or non-invasive mechanical ventilation for more than 12 hours. Analyzes of the variability of mortality and functional impairment at six months will be performed. Likewise, artificial intelligence analyzes ("machine learning" and "neural networks") will be carried out.

Conditions

  • Mechanical Ventilation
  • Usual Care
  • Noninvasive Positive Pressure Ventilation
  • High Flow Oxygen Therapy

Interventions

OTHER

no intervention

no intervention

Sponsors & Collaborators

  • Spanish Research Center for Respiratory Diseases

    collaborator OTHER

  • Hospital Universitario Getafe

    lead OTHER

Principal Investigators

  • Oscar Penuelas, P.h.D · Hospital Universitario de Getafe, Madrid, Spain

Eligibility

Min Age
18 Years
Max Age
119 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-03-01
Completion
2024-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05392010 on ClinicalTrials.gov