Global burden of mechanical ventilation in critically ill patients

Assessment of Clinical Practice of Mechanical Ventilation After COVID-19 Pan-demic Among 57 Countries: A Systematic Analysis for the Global BurdEn of Me-chanIcal VeNtilatIon (GEMINI Study) 2022, From VENTILAGROUP.

This study looks at how mechanical ventilation is used in critically ill patients around the world to see how it affects their recovery and survival.

Quick facts

• Study type: Observational
• Enrollment: 10900 (estimated)
• Ages: 18 Years to 119 Years
• Sex: All
• Sponsor: Hospital Universitario Getafe (other)
• Locations: 1 site (Getafe, Madrid)
• Trial ID: NCT05392010 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the global clinical practices of mechanical ventilation in critically ill patients and assess medium-term clinical outcomes. It will involve the prospective follow-up of adult patients requiring ventilator support across approximately 1525 ICUs in 52 countries. The study seeks to identify phenotypes of critically ill patients that may be associated with increased mortality and functional deterioration, utilizing unsupervised pattern recognition to enhance personalized medicine approaches.

Who should consider this trial

Good fit: Ideal candidates include adult patients aged 18 and older who are admitted to the ICU and require invasive mechanical ventilation for more than 12 hours.

Not a fit: Patients in pediatric ICUs or those in post-operative recovery rooms will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved personalized treatment strategies for critically ill patients requiring mechanical ventilation.

How similar studies have performed: While this study addresses a significant clinical issue, it employs a novel approach to understanding mechanical ventilation practices and outcomes, making it relatively untested in this specific context.

Eligibility criteria

Inclusion Criteria:

* All consecutive adult patients (≥ 18 years old) who are admitted to the ICU and require invasive mechanical ventilation (endotracheal tube or tracheostomy) longer than 12 hours. 2. Adult patients admitted to the ICU and require advanced respiratory support (high flow oxygen nasal cannula \[HFONC\], or noninvasive ventilation \[NIV\] BIPAP or CPAP with oronasal, nasal, helmet or facial mask) with acute respiratory failure defined as PaO2/ fraction of inspired oxygen (FiO2), \[PaO2/FiO2\] ratio \<300, or the pulse oximetric saturation (SpO2/FiO2 ) ratio \< 315 for more than 1 hour. 3. Adult patients in whom mechanical ventilation were started outside the study ICU at the same Institution and/or a different Institution, including Emergency Room, Operating Room (OR), /or were then transferred to the ICU at the participating center

Exclusion Criteria:

* The following ICUs will be excluded:

  1. Pediatric ICU.
  2. Post-Operators Anesthesia Recovery Room. 2. Patients less than 18 years old. 3. Patients admitted after elective surgery and who require mechanical ventilation for less than 12 hours (excepting patients who receive non-invasive ventilation). 4. Patients will be excluded if they were transferred to participating ICUs without a documented intubation time, or underwent a tracheotomy at prior to ICU admission. 5. Patients that were at participating ICUs for 24 hours or more, were readmitted during the study period

Where this trial is running

Getafe, Madrid

• Intensive Care Unit, Hospital Universitario de Getafe — Getafe, Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Oscar Penuelas, P.h.D — Hospital Universitario de Getafe, Madrid, Spain
• Study coordinator: Óscar Penuelas, P.h.D

Conditions: Mechanical Ventilation, Usual Care, Noninvasive Positive Pressure Ventilation, High Flow Oxygen Therapy, mechanical ventilation, mortality, clinical variability, precision medicine