Status:
RECRUITING
Global BurdEn of MechanIcal VeNtilatIon (GEMINI). VeNtilatIon (GEMINI Study) 2022 for VENTILAGROUP.
Lead Sponsor:
Hospital Universitario Getafe
Collaborating Sponsors:
Spanish Research Center for Respiratory Diseases
Conditions:
Mechanical Ventilation
Usual Care
Eligibility:
All Genders
18-119 years
Brief 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 w...
Detailed Description
Patient Population and Participating Centers Research personnel prospectively will follow up all newly admitted adult patients admitted in the ICU who received ventilator support. A region will be def...
Eligibility Criteria
Inclusion
- 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
- The following ICUs will be excluded:
- Pediatric ICU.
- 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
Key Trial Info
Start Date :
October 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
10900 Patients enrolled
Trial Details
Trial ID
NCT05392010
Start Date
October 1 2022
End Date
September 30 2024
Last Update
February 28 2024
Active Locations (1)
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1
Intensive Care Unit, Hospital Universitario de Getafe
Getafe, Madrid, Spain, 28905