Understanding low tidal volume ventilation in patients with acute respiratory failure
Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation Mode in Patients With Acute Respiratory Failure in ICUs in Latin America
This study looks at how often low tidal volume ventilation is used for patients with severe breathing problems in Intensive Care Units in Latin America and its effects on their recovery and ability to breathe on their own.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 422 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 10 sites (Buenos Aires and 9 other locations) |
| Trial ID | NCT06042036 on ClinicalTrials.gov |
What this trial studies
This observational study aims to estimate how often low tidal volume ventilation is used in patients with hypoxemic acute respiratory failure transitioning to spontaneous ventilation in Intensive Care Units across Latin America. It will involve collecting data from 422 patients under mechanical ventilation to assess the prevalence of this ventilation strategy and its impact on patient outcomes, including survival and the ability to remain off ventilatory support. The study will also evaluate the occurrence of significant asynchrony during the transition to spontaneous ventilation modes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with hypoxemic acute respiratory failure requiring mechanical ventilation.
Not a fit: Patients who are tracheostomized, receiving palliative care, or have severe central nervous system injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve ventilation strategies and outcomes for patients with acute respiratory failure.
How similar studies have performed: Other studies have shown success with low tidal volume ventilation approaches, indicating potential for meaningful insights in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Buenos Aires and 9 other locations
- Sanatorio Juncal SA — Buenos Aires, Argentina (Recruiting)
- Hospital Municipal Boliviano Holandés, Universidad Mayor de San Andrés — La Paz, Bolivia (Not_yet_recruiting)
- Hospital das Clínicas -HCFMUSP — Sao Paulo, Sp, Brazil (Recruiting)
- Pontificia Universidad Catolica de Chile — Santiago, Chile (Recruiting)
- Clinica Universidad de la Sabana — Chía, Colombia (Recruiting)
- Hospital Eugenio Espejo — Quito, Ecuador (Recruiting)
- Hospital Civil Fray Antonio Alcalde — Guadalajara, Mexico (Recruiting)
- Hospital San Roque — Asunción, Paraguay (Recruiting)
- Hospital Rebagliati — Lima, Peru (Recruiting)
- Hospital Espanol — Montevideo, Uruguay (Recruiting)
Study contacts
- Principal investigator: Juliana C Ferreira, Md — University of Sao Paulo
- Study coordinator: Fabia D Silva, PhD
- Email: fabiadiniz@usp.br
- Phone: 34992484248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.