Respiration, ArtificialSPIRALNCT06042036
Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation in Patients With Acute Respiratory Failure
An observational study of Respiration, Artificial and Acute Hypoxemic Respiratory Failure, run by University of Sao Paulo General Hospital at 10 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Respiration, Artificial, Acute Hypoxemic Respiratory Failure, Respiratory Insufficiency
- What is being tested?
- Spontaneous mode of mechanical ventilation
- How many people
- 431 participants
- Where
- 10 sitesin 10 countries
- Study dates
- 12 Jun 2023to 15 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hypoxemic ARF, defined as a PaO2/FIO2 ratio <300 mmHg, under controlled invasive mechanical ventilation
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
Bolivia1 site
Hospital Municipal Boliviano Holandés, Universidad Mayor de San Andrés
La Paz
About this study
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
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:
Read more
- 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
Read the 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.
- Being tested
- Spontaneous mode of mechanical ventilation
- Keywords
- Adherence, Treatment, intensive care units
- Medical subject headings
- Respiratory Aspiration, Respiratory Insufficiency, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous mode of mechanical ventilationOther
Also called spontaneous ventilation
any mode of mechanical ventilation classified as spontaneous or proportional, mainly pressure support ventilation, but also CPAP, APRV, NAVA, PAV+
| Study group | Role | What they receive |
|---|---|---|
| acute hypoxemic respiratory failure | Patients with acute hypoxemic respiratory failure transitioning to a spontaneous mode of mechanical ventilation ( PSV, APRV, NAVA, PAV+, CPAP) Receives: Other: Spontaneous mode of mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low tidal volume
Low tidal volume, defined as less or equal to 8 mLs per Kg of predicted body weight
Measured: 24 hours
Ventilator- free days
number of days alive and not receiving invasive mechanical ventilation after transition to spontaneous ventilation
Measured: 28 days
Secondary outcomes (9)
Hospital mortality
mortality in the hospital
Measured: 28 days
Rate of patient-ventilator asynchrony
presence of patient asynchrony 24h after transition to a spontaneous mode of mechanical ventilation
Measured: 24 hours
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
Measured: 24 hours
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
Measured: 24 hours
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
Measured: 28 days
Number of participants that return to sedation after transition to spontaneous ventilation
return to sedation any time after transition to spontaneous ventilation
Measured: 28 days
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
Measured: 24 hours
Number of participants who were extubated
Extubation and discontinuation of mechanical ventilation after the transition to spontaneous mode
Measured: 28 days
Rate of reintubation
Reintubation after transition to spontaneous mode and extubation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start12 Jun 2023
- Primary completion15 Jul 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brazilian Research In Intensive Care Network, Latin American Intensive Care Network (LIVEN)
- Responsible party
- Sponsor
- Investigators
- JULIANA C FERREIRA, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042036
- Sponsor's protocol ID
- 28482720.0.1001.0068
- Acronym
- SPIRAL
- Status last verified
- Oct 2025
- First submitted
- 4 Sep 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data sharing will follow Institutional rules for patient data protection
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06042036
- Acronym / sponsor ID
- SPIRAL / 28482720.0.1001.0068
- Keywords
- Adherence, Treatment, intensive care units
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Brazilian Research In Intensive Care Network, Latin American Intensive Care Network (LIVEN)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute hypoxemic respiratory failure | – | Other: Spontaneous mode of mechanical ventilationPatients with acute hypoxemic respiratory failure transitioning to a spontaneous mode of mechanical ventilation ( PSV, APRV, NAVA, PAV+, CPAP) |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hypoxemic ARF, defined as a PaO2/FIO2 ratio <300 mmHg, under controlled invasive mechanical ventilation
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spontaneous mode of mechanical ventilationAlso: spontaneous ventilationany mode of mechanical ventilation classified as spontaneous or proportional, mainly pressure support ventilation, but also CPAP, APRV, NAVA, PAV+ | Other | acute hypoxemic respiratory failure |
Primary outcome
Low tidal volume
Time frame: 24 hours
Low tidal volume, defined as less or equal to 8 mLs per Kg of predicted body weight
Ventilator- free days
Time frame: 28 days
number of days alive and not receiving invasive mechanical ventilation after transition to spontaneous ventilation
9 secondary outcomes
Hospital mortality
Time frame: 28 days
Rate of patient-ventilator asynchrony
Time frame: 24 hours
Number of participants that return to controlled mechanical ventilation in the first 24 hours
Time frame: 24 hours
Number of participants that return to sedation in the first 24 hours
Time frame: 24 hours
Number of participants that return to controlled mechanical ventilation after transition to spontaneous ventilation
Time frame: 28 days
Number of participants that return to sedation after transition to spontaneous ventilation
Time frame: 28 days
Number of participants with PEEP and FIO2 compatible with the ARDSnet PEEP/FIO2 table
Time frame: 24 hours
Number of participants who were extubated
Time frame: 28 days
Rate of reintubation
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided. data sharing will follow Institutional rules for patient data protection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JULIANA C FERREIRA, MD principal investigator
University of Sao Paulo
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration, Artificial and Acute Hypoxemic Respiratory Failure, run by University of Sao Paulo General Hospital at 10 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Argentina, Bolivia, Brazil, Chile, Colombia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low tidal volume (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.