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| Name | Class |
|---|---|
| Brazilian Research In Intensive Care Network | NETWORK |
| Latin American Intensive Care Network (LIVEN) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acute hypoxemic respiratory failure | Patients with acute hypoxemic respiratory failure transitioning to a spontaneous mode of mechanical ventilation ( PSV, APRV, NAVA, PAV+, CPAP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spontaneous mode of mechanical ventilation | Other | any mode of mechanical ventilation classified as spontaneous or proportional, mainly pressure support ventilation, but also CPAP, APRV, NAVA, PAV+ |
| Measure | Description | Time Frame |
|---|---|---|
| Low tidal volume | Low tidal volume, defined as less or equal to 8 mLs per Kg of predicted body weight | 24 hours |
| Ventilator- free days | number of days alive and not receiving invasive mechanical ventilation after transition to spontaneous ventilation | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital mortality | mortality in the hospital | 28 days |
| Rate of patient-ventilator asynchrony | presence of patient asynchrony 24h after transition to a spontaneous mode of mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with hypoxemic ARF, defined as a PaO2/FIO2 ratio <300 mmHg, under controlled invasive mechanical ventilation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabia D Silva, PhD | Contact | 34992484248 | fabiadiniz@usp.br | |
| Juliana C FERREIRA, MD | Contact | 11983355876 | juliana.ferreira@hc.fm.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| JULIANA C FERREIRA, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanatorio Juncal SA | Recruiting | Buenos Aires | Argentina |
data sharing will follow Institutional rules for patient data protection
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|
| 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 | 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 | 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 | 28 days |
| Number of participants that return to sedation after transition to spontaneous ventilation | return to sedation any time after transition to spontaneous ventilation | 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 | 24 hours |
| Number of participants who were extubated | Extubation and discontinuation of mechanical ventilation after the transition to spontaneous mode | 28 days |
| Rate of reintubation | Reintubation after transition to spontaneous mode and extubation | 28 days |
| Hospital Municipal Boliviano Holandés, Universidad Mayor de San Andrés | Not yet recruiting | La Paz | Bolivia |
|
| Hospital das Clínicas -HCFMUSP | Recruiting | São Paulo | São Paulo | 05403010 | Brazil |
|
| Pontificia Universidad Catolica de Chile | Recruiting | Santiago | Chile |
|
| Clinica Universidad de la Sabana | Recruiting | Chía | Colombia |
|
| Hospital Eugenio Espejo | Recruiting | Quito | Ecuador |
|
| Hospital Civil Fray Antonio Alcalde | Recruiting | Guadalajara | Mexico |
|
| Hospital San Roque | Recruiting | Asunción | Paraguay |
|
| Hospital Rebagliati | Recruiting | Lima | Peru |
|
| Hospital Espanol | Recruiting | Montevideo | Uruguay |
|
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| D012131 | Respiratory Insufficiency |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015438 | Health Behavior |
| D001519 | Behavior |
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