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

NCT06195475 | Completed

• 1 other identifier: Sanatorio Anchorena San Martín
• Study Type: observational
• Target: 2,607
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pressure support ventilation; tidal volume

Outcome Measures

Primary Outcomes (1)

• 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.

  day 28

Secondary Outcomes (3)

• Failure in transitioning to spontaneous ventilation

  72 hours

• Ventilator-free days

  28 days

• ICU length of stay

  28 days

Study Arms (2)

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

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

Interventions

high vs low tidal volume OTHER

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.

exposure to tidal volumes greater than 8 ml/kg of predicted body weight; tidal volume equal to or less than 8 ml/kg of predicted body weight

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanatorio Anchorena San Martin: lead
• Javier Hernán Dorado: collaborator
• Joaquin Perez: collaborator

Study Sites (1)

Sanatorio Anchorena San Martín

Buenos Aires, Buenos Aires, 1672, Argentina

Location

Related Publications (17)

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  PMID: 10816184 BACKGROUND

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  PMID: 18191684 BACKGROUND

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  PMID: 31691042 BACKGROUND

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Related Links

• Mark Stevenson, Evan Sergeant with contributions from Telmo Nunes, Cord Heuer, Jonathon Marshall, Javier Sanchez, Ron Thornton, Jeno Reiczigel, Jim Robison-Cox, Paola Sebastiani, Peter Solymos, Kazuki Yoshida, Geoff Jones, Sarah Pirika

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respiratory and physical therapist

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: January 8, 2024
• Study Start: November 30, 2023
• Primary Completion: April 15, 2024
• Study Completion: October 15, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)