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

November 14, 2023 updated by: University of Sao Paulo General Hospital

Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation Mode in Patients With Acute Respiratory Failure in ICUs in Latin America

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

422

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Sanatorio Juncal SA
        • Contact:
          • Pablo Gomez
  • Bolivia
      • La Paz, Bolivia
        • Not yet recruiting
        • Hospital Municipal Boliviano Holandés, Universidad Mayor de San Andrés
        • Contact:
          • Adrian Avilla
  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403010
        • Recruiting
        • Hospital das Clínicas -HCFMUSP
        • Contact:
          • Juliana C Ferreira, MD
          • Phone Number: +5511983355876
        • Principal Investigator:
          • juliana ferreira, MD
  • Chile
      • Santiago, Chile
        • Recruiting
        • Pontificia Universidad Católica de Chile
        • Contact:
          • Alejandro Bruhn
  • Colombia
      • Chía, Colombia
        • Recruiting
        • Clínica Universidad De la Sabana
        • Contact:
          • Luis Felipe Reyes
  • Ecuador
      • Quito, Ecuador
        • Recruiting
        • Hospital Eugenio Espejo
        • Contact:
          • Manuel Jibaja
  • Mexico
      • Guadalajara, Mexico
        • Recruiting
        • Hospital Civil Fray Antonio Alcalde
        • Contact:
          • Miguel Ibarra
  • Paraguay
      • Asunción, Paraguay
        • Recruiting
        • Hospital San Roque
        • Contact:
          • Gabriel Preda
  • Peru
      • Lima, Peru
        • Recruiting
        • Hospital Rebagliati
        • Contact:
          • Rollin Roldan
  • Uruguay
      • Montevideo, Uruguay
        • Recruiting
        • Hospital Español
        • Contact:
          • Nicolas Nin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
any mode of mechanical ventilation classified as spontaneous or proportional, mainly pressure support ventilation, but also CPAP, APRV, NAVA, PAV+
Other Names:
  • spontaneous ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low tidal volume
Time Frame: 24 hours
Low tidal volume, defined as less or equal to 8 mLs per Kg of predicted body weight
24 hours
Ventilator- free days
Time Frame: 28 days
number of days alive and not receiving invasive mechanical ventilation after transition to spontaneous ventilation
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital mortality
Time Frame: 28 days
mortality in the hospital
28 days
Rate of patient-ventilator asynchrony
Time Frame: 24 hours
presence of patient asynchrony 24h after transition to a spontaneous mode of mechanical ventilation
24 hours
Number of participants that return to controlled mechanical ventilation in the first 24 hours
Time Frame: 24 hours
return to controlled mechanical ventilation in the first 24 hours after transition to spontaneous ventilation
24 hours
Number of participants that return to sedation in the first 24 hours
Time Frame: 24 hours
return to sedation in the first 24 hours after transition to spontaneous ventilation
24 hours
Number of participants that return to controlled mechanical ventilation after transition to spontaneous ventilation
Time Frame: 28 days
return to controlled mechanical ventilation any time after transition to spontaneous ventilation
28 days
Number of participants that return to sedation after transition to spontaneous ventilation
Time Frame: 28 days
return to sedation any time after transition to spontaneous ventilation
28 days
Number of participants with PEEP and FIO2 compatible with the ARDSnet PEEP/FIO2 table
Time Frame: 24 hours
adherence to ARDSnet low PEEP/FIO2 table after transition to spontaneous ventilation
24 hours
Number of participants who were extubated
Time Frame: 28 days
Extubation and discontinuation of mechanical ventilation after the transition to spontaneous mode
28 days
Rate of reintubation
Time Frame: 28 days
Reintubation after transition to spontaneous mode and extubation
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Brazilian Research In Intensive Care Network
Latin American Intensive Care Network (LIVEN)

Investigators

  • Principal Investigator: Juliana C Ferreira, MD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2023

Primary Completion (Estimated)

June 12, 2024

Study Completion (Estimated)

October 12, 2024

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28482720.0.1001.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

data sharing will follow Institutional rules for patient data protection

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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