The goal of this Multicenter retrospective cohort study is to assessing the association between the development of a tidal volume magnitude \> 8 ml/kg of predicted body weight during the first transition to partial support phase in pressure support mode and mortality in the intensive care unit in a general population of patients older than 18 years who require invasive mechanical ventilation, in contrast to individuals who develop tidal volume ≤ 8 ml/kg of predicted body weight. Secondarily, assess the association between elevated VT (tidal volume) during the initiation of the partial support phase in pressure support mode and ventilator-free days, failure in transitioning to spontaneous ventilation, and success in weaning from mechanical ventilation. The main question it aims to answer are: • Does exposure to tidal volumes greater than 8 ml/kg of predicted body weight during the first 48 hours of pressure support mode mechanical ventilation increase the risk of death in the intensive care unit compared to those who develop a tidal volume equal to or less than 8 ml/kg of predicted body weight in subjects older than 18 years requiring invasive mechanical ventilation? The clinical investigation aims to determine whether exposure to tidal volumes greater than 8 ml/kg of predicted body weight during the initial 48 hours of pressure support mode mechanical ventilation is associated with an increased risk of mortality in the intensive care unit when compared to individuals who maintain a tidal volume equal to or less than 8 ml/kg of predicted body weight. This analysis involves subjects aged 18 years and older who require invasive mechanical ventilation
The data of patients from each participating center in the study will be encoded to maintain their anonymity. These center-related data will only be known to the study's Principal Investigator (PI), who will be the sole individual with access to them. Under no circumstances will the centers be able to make comparisons among themselves. The data collected by each participating unit will be gathered by the investigator or by one of the designated team members assigned to the study, and entered into a REDCap® form specifically designed for this study. The data collected by each investigator will be randomly supervised by the coordinating group to ensure the quality of the collected data and to detect possible errors in data acquisition. The study's coordinating group will also monitor the daily incorporation of data into the database to supervise and detect, as a double filter, the possibility of errors in data editing and incorporation, thus ensuring the quality and reliability of the information obtained throughout the entire period of patient inclusion.
Study Type
OBSERVATIONAL
Enrollment
2,607
The clinical investigation aims to determine whether exposure to tidal volumes greater than 8 ml/kg of predicted body weight during the initial 72 hours of pressure support mode mechanical ventilation is associated with an increased risk of mortality in the intensive care unit when compared to individuals who maintain a tidal volume equal to or less than 8 ml/kg of predicted body weight.
Sanatorio Anchorena San Martín
Buenos Aires, Buenos Aires, Argentina
mortality in intensive care unit
Categorical dichotomous variable (yes/no). All patients who are discharged from the intensive care unit (ICU), regardless of their destination (another area within the institution or another healthcare facility of any kind), will be considered as alive at ICU discharge.
Time frame: day 28
Failure in transitioning to spontaneous ventilation
Categorical dichotomous variable (yes/no). It will be considered a failure in transitioning to spontaneous ventilation for any subject who, after having at least one monitoring session in PC-CSV mode, has at least one monitoring session in mandatory modes (VC-CMV and/or PC-CMV) within the following 72 hours.
Time frame: 72 hours
Ventilator-free days
Discrete quantitative variable. To count each day of mechanical ventilation (MV), daily programming and respiratory mechanics monitoring will be used; considering one monitoring session as one day of MV. To obtain the final variable, the following equation will be used: 28 - days of invasive MV, resulting in a possible data range from 0 to 26 ventilator-free days.
Time frame: 28 days
ICU length of stay
Discrete quantitative variable. It will be obtained using the following equation: (Date of ICU discharge) - (Date of ICU admission). Only the number of days of hospitalization will be required for the analysis.
Time frame: 28 days
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