An observational study in Respiration, Artificial, Acute Hypoxemic Respiratory Failure and Respiratory Insufficiency, sponsored by University of Sao Paulo General Hospital. Completed at 10 sites in 10 countries. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by University of Sao Paulo General Hospital · Observational
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:
Participants are patients with acute respiratory failure under mechanical ventilation. Investigators will collect data on the ventilatory parameters of participants
Investigators will collect several patient-centered clinical outcomes at 28 days after study inclusion, including ventilator-free days and mortality
Investigators will conduct a cohort study in Intensive Care Units (ICUs) across Latin America, aiming to include 422 patients with Hypoxemic Acute Respiratory Failure (ARF) and under invasive mechanical ventilation.
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
The primary objectives are to determine the prevalence of low tidal volume ventilation (VT \< 8 mL/kg of predicted body weight) during the initial 24 hours of spontaneous ventilatory modes in patients diagnosed with hypoxemic ARF and its association with clinically important patient outcomes. Investigators are interested in assessing the rate of adherence to low tidal volume ventilation, defined as maintaining VT \< 8 mL/kg of predicted body weight during the first 24 hours of ventilation in spontaneous mode.They are also interested in measuring the number of days that patients are alive and not receiving ventilatory support and survival at 28 days.
Investigators will also measure the proportion of patients experiencing significant asynchrony during the transition to spontaneous mechanical ventilation, who revert to sedation and controlled mechanical ventilation within the first 24 hours or at any point during mechanical ventilation.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's enrollment of 431 is above the median of 100 across 455 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with hypoxemic ARF, defined as a PaO2/FIO2 ratio \<300 mmHg, under controlled invasive mechanical ventilation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with acute hypoxemic respiratory failure transitioning to a spontaneous mode of mechanical ventilation ( PSV, APRV, NAVA, PAV+, CPAP)
Other: Spontaneous mode of mechanical ventilation
any mode of mechanical ventilation classified as spontaneous or proportional, mainly pressure support ventilation, but also CPAP, APRV, NAVA, PAV+
Also known as: spontaneous ventilation
Low tidal volume
Low tidal volume, defined as less or equal to 8 mLs per Kg of predicted body weight
Time frame: 24 hours
Ventilator- free days
number of days alive and not receiving invasive mechanical ventilation after transition to spontaneous ventilation
Time frame: 28 days
Hospital mortality
mortality in the hospital
Time frame: 28 days
Rate of patient-ventilator asynchrony
presence of patient asynchrony 24h after transition to a spontaneous mode of mechanical ventilation
Time frame: 24 hours
Number of participants that return to controlled mechanical ventilation in the first 24 hours
return to controlled mechanical ventilation in the first 24 hours after transition to spontaneous ventilation
Time frame: 24 hours
Number of participants that return to sedation in the first 24 hours
return to sedation in the first 24 hours after transition to spontaneous ventilation
Time frame: 24 hours
Number of participants that return to controlled mechanical ventilation after transition to spontaneous ventilation
return to controlled mechanical ventilation any time after transition to spontaneous ventilation
Time frame: 28 days
Number of participants that return to sedation after transition to spontaneous ventilation
return to sedation any time after transition to spontaneous ventilation
Time frame: 28 days
Number of participants with PEEP and FIO2 compatible with the ARDSnet PEEP/FIO2 table
adherence to ARDSnet low PEEP/FIO2 table after transition to spontaneous ventilation
Time frame: 24 hours
Number of participants who were extubated
Extubation and discontinuation of mechanical ventilation after the transition to spontaneous mode
Time frame: 28 days
Rate of reintubation
Reintubation after transition to spontaneous mode and extubation
Time frame: 28 days
Plan to share: Undecided — data sharing will follow Institutional rules for patient data protection
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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