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Association Between Tidal Volume and Mortality in Pressure Support in Adults Under Invasive Mechanical Ventilation

NCT06195475 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2607

Last updated 2025-05-15

No results posted yet for this study

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

Conditions

  • Respiration, Artificial

Interventions

OTHER

high vs low tidal volume

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.

Sponsors & Collaborators

  • Javier Hernán Dorado

    collaborator UNKNOWN

  • Joaquin Perez

    collaborator UNKNOWN

  • Sanatorio Anchorena San Martin

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-04-15
Completion
2024-10-15

Countries

  • Argentina

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06195475 on ClinicalTrials.gov