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

Respiratory Insufficiency Clinical Trial

— SPIRAL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06042036
• Other study ID #: 28482720.0.1001.0068
• Status: Recruiting
• Start date: June 12, 2023
• Est. completion date: October 12, 2024

Study information

• Verified date: September 2023
• Source: University of Sao Paulo General Hospital
• Contact: Fabia D Silva, PhD
• Phone: 34992484248
• Email: fabiadiniz[@]usp.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 422
• Est. completion date: October 12, 2024
• Est. primary completion date: June 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Respiration, Artificial
• Respiratory Insufficiency

Intervention

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+

Locations

Country	Name	City	State
Argentina	Sanatorio Juncal SA	Buenos Aires
Bolivia	Hospital Municipal Boliviano Holandés, Universidad Mayor de San Andrés	La Paz
Brazil	Hospital das Clínicas -HCFMUSP	Sao Paulo	SP
Chile	Pontificia Universidad Catolica de Chile	Santiago
Colombia	Clinica Universidad de la Sabana	Chía
Ecuador	Hospital Eugenio Espejo	Quito
Mexico	Hospital Civil Fray Antonio Alcalde	Guadalajara
Paraguay	Hospital San Roque	Asunción
Peru	Hospital Rebagliati	Lima
Uruguay	Hospital Espanol	Montevideo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Brazilian Research In Intensive Care Network, Latin American Intensive Care Network (LIVEN)

Countries where clinical trial is conducted

Argentina,  Bolivia,  Brazil,  Chile,  Colombia,  Ecuador,  Mexico,  Paraguay,  Peru,  Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low tidal volume	Low tidal volume, defined as less or equal to 8 mLs per Kg of predicted body weight	24 hours
Primary	Ventilator- free days	number of days alive and not receiving invasive mechanical ventilation after transition to spontaneous ventilation	28 days
Secondary	Hospital mortality	mortality in the hospital	28 days
Secondary	Rate of patient-ventilator asynchrony	presence of patient asynchrony 24h after transition to a spontaneous mode of mechanical ventilation	24 hours
Secondary	Number of participants that return to controlled mechanical ventilation in the first 24 hours	return to controlled mechanical ventilation in the first 24 hours after transition to spontaneous ventilation	24 hours
Secondary	Number of participants that return to sedation in the first 24 hours	return to sedation in the first 24 hours after transition to spontaneous ventilation	24 hours
Secondary	Number of participants that return to controlled mechanical ventilation after transition to spontaneous ventilation	return to controlled mechanical ventilation any time after transition to spontaneous ventilation	28 days
Secondary	Number of participants that return to sedation after transition to spontaneous ventilation	return to sedation any time after transition to spontaneous ventilation	28 days
Secondary	Number of participants with PEEP and FIO2 compatible with the ARDSnet PEEP/FIO2 table	adherence to ARDSnet low PEEP/FIO2 table after transition to spontaneous ventilation	24 hours
Secondary	Number of participants who were extubated	Extubation and discontinuation of mechanical ventilation after the transition to spontaneous mode	28 days
Secondary	Rate of reintubation	Reintubation after transition to spontaneous mode and extubation	28 days