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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05392010
Other study ID # GEMINI/0422
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date September 30, 2024

Study information

Verified date February 2024
Source Hospital Universitario Getafe
Contact Óscar Penuelas, P.h.D
Phone +34916834982
Email openuelas@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
Spain Intensive Care Unit, Hospital Universitario de Getafe Getafe Madrid

Sponsors (2)

Lead Sponsor Collaborator
Hospital Universitario Getafe Spanish Research Center for Respiratory Diseases

Country where clinical trial is conducted

Spain, 

References & Publications (17)

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Outcome

Type Measure Description Time frame Safety issue
Primary ICU mortality rate of dead patients requiring mechanical ventilation during ICU stay From date of inclusion until the date of death from any cause during ICU stay, whichever came first, assessed up to 6 weeks
Secondary hospital mortality. rate of dead patients requiring mechanical ventilation during hospital stay From date of inclusion until the date of death from any cause during hospital stay, whichever came first, assessed up to 6 months
Secondary duration of mechanical ventilation. length of invasive ventilatory support from orotracheal intubation date until scheduled extubation date or 24 hours of unassisted respiratory support in tracheotomized patietns
Secondary 28-day mortality. rate of dead patients requiring mechanical ventilation until 28-day hospital stay from initiacion from mechanical ventilation until 28-day hospital stay.
Secondary 6 months mortality rate of dead patients requiring 3 days of mechanical ventilation after hospital discharge from hospital discharge date until 6 months of follow-up in surviors from ICU stay.
Secondary 6-months frailty. assessment of clinical frailty scale at 6-months after hospital discharge. from hospital discharge date until 6 months of follow-up in surviors from ICU stay, assessed by Clinical Frailty Scale (CFS, where values between 1-9 points, a higher scores mean a worse outcome)
Secondary reintubation. rate of failed extubated patients following 48 hours from scheduled extubation From date of orotracheal scheduled extubation until the date of reintubation from any cause during ICU stay, assessed up to 48 hours
Secondary ICU stay. length of ICU stay. From date of inclusion (ICU admission) until the date of ICU discharge, assessed up to 6 weeks, including survivors and nonsurvivors from ICU
Secondary hospital stay. length of hospital stay. From date of inclusion (ICU admission) until the date of hospital discharge, assessed up to 6 monthss including survivors and nonsurvivors from ICU
Secondary ICU free days. It will defined the ICU-free days as 30 minus the number of days in the ICU (range, 0-30 days). For patients who survived and were in the ICU for less than 30 days, the ICU-free day's outcome measure was obtained by subtracting the length of the ICU stay from 30 events during ICU stay (from ICU admission to ICU discharge dates)
Secondary ventilator-free days (VFD). VFD will be defined as follows:
VFDs = 0 if subject dies within 28 days of mechanical ventilation.
VFDs = 28 - x if successfully liberated from ventilation x days after initiation.
VFDs = 0 if the subject is mechanically ventilated for >28 days
events during ICU stay (from ICU admission to ICU discharge dates) From date of orotracheal intubation until the date of unassisted positive pressure ventilation, either without orotracheal tube or tracheal cannula, assessed up to 6 months
Secondary tracheotomy rate. rate of tracheotomized patients in those patients receiving invasive mechanical ventilation events during ICU stay (rate of performance for scheduled tracheotomy, assessed up to 6 months)
Secondary decision for withdrawal or withholding vital support rate. rate of those patients that will have a decision for withdrawal or withholding vital support rate during ICU stay events during ICU admission through study completion, an average of 6 months.
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