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.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 119
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Intensive Care Unit, Hospital Universitario de Getafe
RECRUITING
Getafe
Contact Information
Primary
Óscar Penuelas, P.h.D
openuelas@gmail.com
+34916834982
Backup
Fernando Frutos-Vivar, M.D
fernando.frutos@salud.madrid.org
+34916834982
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2024-09-30
Participants
Target number of participants: 10900
Treatments
ventilated critically ill patients
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.
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitario Getafe
Collaborators: Spanish Research Center for Respiratory Diseases

This content was sourced from clinicaltrials.gov