Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation in Patients With Acute Respiratory Failure
NCT ID: NCT06042036
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
422 participants
OBSERVATIONAL
2023-06-12
2024-10-12
Brief Summary
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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
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Detailed Description
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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
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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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acute hypoxemic respiratory failure
Patients with acute hypoxemic respiratory failure transitioning to a spontaneous mode of mechanical ventilation ( PSV, APRV, NAVA, PAV+, CPAP)
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+
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
110 Years
ALL
No
Sponsors
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Brazilian Research In Intensive Care Network
NETWORK
Latin American Intensive Care Network (LIVEN)
UNKNOWN
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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JULIANA C FERREIRA, MD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Sanatorio Juncal SA
Buenos Aires, , Argentina
Hospital Municipal Boliviano Holandés, Universidad Mayor de San Andrés
La Paz, , Bolivia
Hospital das Clínicas -HCFMUSP
São Paulo, São Paulo, Brazil
Pontificia Universidad Catolica de Chile
Santiago, , Chile
Clinica Universidad de la Sabana
Chía, , Colombia
Hospital Eugenio Espejo
Quito, , Ecuador
Hospital Civil Fray Antonio Alcalde
Guadalajara, , Mexico
Hospital San Roque
Asunción, , Paraguay
Hospital Rebagliati
Lima, , Peru
Hospital Espanol
Montevideo, , Uruguay
Countries
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Central Contacts
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Facility Contacts
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Pablo Gomez
Role: primary
Adrian Avilla
Role: primary
Juliana C Ferreira, MD
Role: primary
Alejandro Bruhn
Role: primary
Luis Felipe Reyes
Role: primary
Manuel Jibaja
Role: primary
Miguel Ibarra
Role: primary
Gabriel Preda
Role: primary
Rollin Roldan
Role: primary
Nicolas Nin
Role: primary
Other Identifiers
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28482720.0.1001.0068
Identifier Type: -
Identifier Source: org_study_id
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