UnknownNot Applicable

Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation in Patients With Acute Respiratory Failure

Argentina, Bolivia, Brazil422 participantsStarted 2023-06-12

Plain-language summary

The goal of this observational study is to estimate the prevalence of the use of protective ventilation with low tidal volume ventilation in the transition of spontaneous ventilation modes in patients with hypoxemic acute respiratory failure in ICUs in Latin America and its association with patient outcomes. The main questions it aims to answer are: * what is the prevalence of the use of low tidal volume ventilation (VT \<8 mL/kg of predicted body weight) in the first 24 hours of spontaneous ventilation modes in patients with hypoxemic acute respiratory failure? * Is there an association between the rate of adherence to low tidal volume ventilation in spontaneous ventilation modes and the ability to stay off ventilatory support and mortality? Participants are patients with acute respiratory failure under mechanical ventilation. Investigators will collect data on the ventilatory parameters of participants * 24 hours before they begin to be ventilated with spontaneous modes of ventilation * during the first 24 hours of spontaneous ventilation Investigators will collect several patient-centered clinical outcomes at 28 days after study inclusion, including ventilator-free days and mortality

Who can participate

Age range

18 Years – 110 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years * Patients with hypoxemic ARF, defined as a PaO2/FIO2 ratio \<300 mmHg, under controlled invasive mechanical ventilation, with an expected duration of MV of at least 24h. * Patients transitioning to spontaneous ventilation modes (PSV, PAV Plus, NAVA or APRV) Exclusion Criteria: * Tracheostomized patients. * Decision not to maintain or add life support measures on the day of assessment (palliative care). * Patient in ECMO. * Air fistula or barotrauma that prevents adequate tidal volume monitoring. * Severe injuries to the central nervous system that result in abolished or very high respiratory drive, for whom it is not possible to maintain protective tidal volume.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Low tidal volume

Timeframe: 24 hours

Ventilator- free days

Timeframe: 28 days

Trial details

NCT IDNCT06042036

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-12

Contact for this trial

Fabia D Silva, PhD

34992484248 fabiadiniz@usp.br

View on ClinicalTrials.gov More Respiration, Artificial trials