Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation in Patients With Acute Respiratory Failure

Recruiting

• Conditions: Acute Hypoxemic Respiratory Failure; Respiration, Artificial; Respiratory Insufficiency
• Interventions: Other: Spontaneous mode of mechanical ventilation

• Registration Number: NCT06042036
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2023-06-12
• Status Verified: 2023-09
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-11
• Study First Posted: 2023-09-18
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-06-12
• Study Completion: 2024-10-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 422

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
acute hypoxemic respiratory failure	Spontaneous mode of mechanical ventilation	Patients with acute hypoxemic respiratory failure transitioning to a spontaneous mode of mechanical ventilation ( PSV, APRV, NAVA, PAV+, CPAP)

Primary Outcome Measures

Name	Time	Method
Ventilator- free days	28 days	number of days alive and not receiving invasive mechanical ventilation after transition to spontaneous ventilation
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

Name	Time	Method
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 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
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 in the first 24 hours	24 hours	return to sedation in the first 24 hours after transition to spontaneous ventilation
Rate of reintubation	28 days	Reintubation after transition to spontaneous mode and extubation
Number of participants that return to sedation after transition to spontaneous ventilation	28 days	return to sedation any time after transition to spontaneous ventilation

Trial Locations

Locations (10)

Hospital Municipal Boliviano Holandés, Universidad Mayor de San Andrés; 🇧🇴 La Paz, Bolivia

Pontificia Universidad Catolica de Chile; 🇨🇱 Santiago, Chile

Clinica Universidad de la Sabana; 🇨🇴 Chía, Colombia

Hospital Eugenio Espejo; 🇪🇨 Quito, Ecuador

Hospital Espanol; 🇺🇾 Montevideo, Uruguay

Sanatorio Juncal SA; 🇦🇷 Buenos Aires, Argentina

Hospital Civil Fray Antonio Alcalde; 🇲🇽 Guadalajara, Mexico

Hospital San Roque; 🇵🇾 Asunción, Paraguay

Hospital Rebagliati; 🇵🇪 Lima, Peru

Hospital das Clínicas -HCFMUSP; 🇧🇷 Sao Paulo, SP, Brazil