Clinical trial NCT06042036: Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation in Patients With Acute Respiratory Failure
Official title: Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation Mode in Patients With Acute Respiratory Failure in ICUs in Latin America
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiration, Artificial
Acute Hypoxemic Respiratory Failure
Respiratory Insufficiency
Keywords: Adherence, Treatment
intensive care units
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Brazilian Research In Intensive Care Network
name: Latin American Intensive Care Network (LIVEN)
First posted: 2023-09-18
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hypoxemic ARF, defined as a PaO2/FIO2 ratio \<300 mmHg, under controlled invasive mechanical ventilation

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 and its association with patient outcomes.

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

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 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.

Eligibility 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.

Primary outcomes:
measure: Low tidal volume
timeFrame: 24 hours
measure: Ventilator- free days
timeFrame: 28 days
Secondary outcomes:
measure: Hospital mortality
timeFrame: 28 days
measure: Rate of patient-ventilator asynchrony
timeFrame: 24 hours
measure: Number of participants that return to controlled mechanical ventilation in the first 24 hours
timeFrame: 24 hours
measure: Number of participants that return to sedation in the first 24 hours
timeFrame: 24 hours
measure: Number of participants that return to controlled mechanical ventilation after transition to spontaneous ventilation
timeFrame: 28 days
measure: Number of participants that return to sedation after transition to spontaneous ventilation
timeFrame: 28 days
measure: Number of participants with PEEP and FIO2 compatible with the ARDSnet PEEP/FIO2 table
timeFrame: 24 hours
measure: Number of participants who were extubated
timeFrame: 28 days
measure: Rate of reintubation
timeFrame: 28 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Sanatorio Juncal SA
city: La Paz
country: Bolivia
facility: Hospital Municipal Boliviano Holandés, Universidad Mayor de San Andrés
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas -HCFMUSP
state: SP
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
city: Chía
country: Colombia
facility: Clinica Universidad de la Sabana
city: Quito
country: Ecuador
facility: Hospital Eugenio Espejo
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
city: Asunción
country: Paraguay
facility: Hospital San Roque
city: Lima
country: Peru
facility: Hospital Rebagliati
city: Montevideo
country: Uruguay
facility: Hospital Espanol
Study officials:
affiliation: University of Sao Paulo
name: JULIANA C FERREIRA, MD
role: PRINCIPAL_INVESTIGATOR
References: