SPIRAL: Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation in Patients With Acute Respiratory Failure
Study Details
Study Description
Brief 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
The main questions it aims to answer are:
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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?
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Is there an association between the rate of adherence to low tidal volume ventilation in spontaneous ventilation modes and mortality?
Participants are patients with acute respiratory failure under mechanical ventilation. Investigators will collect data on the ventilatory parameters of participants
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24 hours before they begin to be ventilated with spontaneous modes of ventilation
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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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 objective is 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. Investigators are primarily 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.
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. Finally, 28-day hospital survival will be measured
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| acute hypoxemic respiratory failure 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+
Other Names:
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Outcome Measures
Primary Outcome Measures
- Low tidal volume [24 hours]
Low tidal volume, defined as less or equal to 8 mLs per Kg of predicted body weight
Secondary Outcome Measures
- Hospital mortality [28 days]
mortality in the hospital
- Rate of patient-ventilator asynchrony [24 hours]
presence of patient asynchrony 24h after transition to a spontaneous mode of mechanical ventilation
- Number of participants that return to controlled mechanical ventilation in the first 24 hours [24 hours]
return to controlled mechanical ventilation in the first 24 hours after transition to spontaneous ventilation
- Number of participants that return to sedation in the first 24 hours [24 hours]
return to sedation in the first 24 hours after transition to spontaneous ventilation
- Number of participants that return to controlled mechanical ventilation after transition to spontaneous ventilation [28 days]
return to controlled mechanical ventilation any time after transition to spontaneous ventilation
- Number of participants that return to sedation after transition to spontaneous ventilation [28 days]
return to sedation any time after transition to spontaneous ventilation
- Ventilator- free days [28 days]
number of days alive and not receiving invasive mechanical ventilation after transition to spontaneous ventilation
- Number of participants with PEEP and FIO2 compatible with the ARDSnet PEEP/FIO2 table [24 hours]
adherence to ARDSnet low PEEP/FIO2 table after transition to spontaneous ventilation
- Number of participants who were extubated [28 days]
Extubation and discontinuation of mechanical ventilation after the transition to spontaneous mode
- Rate of reintubation [28 days]
Reintubation after transition to spontaneous mode and extubation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years
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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.
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Patients transitioning to spontaneous ventilation modes (PSV, PAV Plus, NAVA or APRV)
Exclusion Criteria:
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Tracheostomized patients.
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Decision not to maintain or add life support measures on the day of assessment (palliative care).
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Patient in ECMO.
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Air fistula or barotrauma that prevents adequate tidal volume monitoring.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanatorio Juncal SA | Buenos Aires | Argentina | ||
| 2 | Hospital Municipal Boliviano Holandés, Universidad Mayor de San Andrés | La Paz | Bolivia | ||
| 3 | Hospital das Clínicas -HCFMUSP | Sao Paulo | SP | Brazil | 05403010 |
| 4 | Pontificia Universidad Catolica de Chile | Santiago | Chile | ||
| 5 | Clinica Universidad de la Sabana | Chía | Colombia | ||
| 6 | Hospital Eugenio Espejo | Quito | Ecuador | ||
| 7 | Hospital Civil Fray Antonio Alcalde | Guadalajara | Mexico | ||
| 8 | Hospital San Roque | Asunción | Paraguay | ||
| 9 | Hospital Rebagliati | Lima | Peru | ||
| 10 | Hospital Espanol | Montevideo | Uruguay |
Sponsors and Collaborators
- University of Sao Paulo General Hospital
- Brazilian Research In Intensive Care Network
- Liven
Investigators
- Principal Investigator: JULIANA C FERREIRA, MD, University of Sao Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 28482720.0.1001.0068