Association Between Tidal Volume and Mortality in Pressure Support in Adults Under Invasive Mechanical Ventilation (SAFE-VT)

May 12, 2025 updated by: Matias Accoce, Sanatorio Anchorena San Martin

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 (Actual)

2607

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1672
        • Sanatorio Anchorena San Martín

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 years or older in invasive mechanical ventilation who have remained in PC-CSV for at least 24 hours

Description

Inclusion Criteria:

  • Patients aged 18 and older admitted to the participating ICUs from January 1, 2019, to April 30, 2023, with a requirement for mechanical ventilation (MV) for any reason for at least 72 hours within the same cycle, who have at least one monitoring session in PC-CSV (pressure support ventilation), and who remain on MV (regardless of the mode) for a period of ≥ 1 calendar day after that monitoring session will be included

Exclusion Criteria:

  • Patients who have not initiated the partial support phase in PC-CSV mode or who are extubated within a period of less than 24 hours from the first ventilatory monitoring in PC-CSV will be excluded. Subjects with missing data in exposure and/or outcome variables will also be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
exposure to tidal volumes greater than 8 ml/kg of predicted body weight
exposure to tidal volumes greater than 8 ml/kg of predicted body weight during the initial 48 hours of pressure support mode mechanical ventilation
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.
tidal volume equal to or less than 8 ml/kg of predicted body weight
individuals who maintain a tidal volume equal to or less than 8 ml/kg of predicted body weight
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality in intensive care unit
Time Frame: day 28
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.
day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure in transitioning to spontaneous ventilation
Time Frame: 72 hours
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.
72 hours
Ventilator-free days
Time Frame: 28 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.
28 days
ICU length of stay
Time Frame: 28 days
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanatorio Anchorena San Martin

Collaborators

Javier Hernán Dorado
Joaquin Perez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2023

Primary Completion (Actual)

April 15, 2024

Study Completion (Actual)

October 15, 2024

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sanatorio Anchorena San Martín

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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