CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,607 enrolled
Drug / intervention
high vs low tidal volumeother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06195475
NCT06195475N/ACompleted

Impact of Tidal Volume Magnitude in Pressure Support Mode on Mortality in Adults Under Invasive Mechanical Ventilation. Multi-center Retrospective Cohort Study.

Sanatorio Anchorena San Martin·observational·Posted Jan 8, 2024·Updated May 15, 2025

In Brief

An observational study evaluating high vs low tidal volume for Respiration, Artificial. Completed, enrolled 2,607 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesArgentina

Timeline

N/ACompletedFinished
202420252026
First PostedJan 8, 2024
Enrollment StartNov 30, 2023
Primary CompletionApr 15, 2024
Study CompletionOct 15, 2024
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 2.5 years ago

Interventions

high vs low tidal volumeother

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.