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

NCT06042036 | Unknown

• 1 other identifier: 28482720.0.1001.0068
• Study Type: observational
• Target: 422
• Locations: 10 countries
• Sites: 10

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

Conditions

Respiration, Artificial; Acute Hypoxemic Respiratory Failure; Respiratory Insufficiency

Keywords

Adherence, Treatment; intensive care units

Outcome Measures

Primary Outcomes (2)

• Low tidal volume

  Low tidal volume, defined as less or equal to 8 mLs per Kg of predicted body weight

  24 hours

• Ventilator- free days

  number of days alive and not receiving invasive mechanical ventilation after transition to spontaneous ventilation

  28 days

Secondary Outcomes (9)

• Hospital mortality

  28 days

• Rate of patient-ventilator asynchrony

  24 hours

• Number of participants that return to controlled mechanical ventilation in the first 24 hours

  24 hours

• Number of participants that return to sedation in the first 24 hours

  24 hours

• Number of participants that return to controlled mechanical ventilation after transition to spontaneous ventilation

  28 days

Study Arms (1)

acute hypoxemic respiratory failure

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

Other: Spontaneous mode of mechanical ventilation

Interventions

Spontaneous mode of mechanical ventilation OTHER

any mode of mechanical ventilation classified as spontaneous or proportional, mainly pressure support ventilation, but also CPAP, APRV, NAVA, PAV+

Also known as: spontaneous ventilation

acute hypoxemic respiratory failure

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypoxemic ARF, defined as a PaO2/FIO2 ratio \<300 mmHg, under controlled invasive mechanical ventilation

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Brazilian Research In Intensive Care Network: collaborator
• Latin American Intensive Care Network (LIVEN): collaborator

Study Sites (10)

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

São Paulo, São Paulo, 05403010, 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

MeSH Terms

Conditions

Respiratory Aspiration; Respiratory Insufficiency; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Officials

• JULIANA C FERREIRA, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabia D Silva, PhD

CONTACT

34992484248; fabiadiniz@usp.br

Juliana C FERREIRA, MD

CONTACT

11983355876; juliana.ferreira@hc.fm.usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 18, 2023
• Study Start: June 12, 2023
• Primary Completion: June 12, 2024
• Study Completion: October 12, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-09

Locations

BO (1); PE (1); EC (1); CO (1); AR (1); PA (1); BR (1); ME (1); UR (1); CL (1)