Acute Hypoxemic Respiratory FailureAPPOINTNCT05853068
Assessment of PaO2/FiO2 Ratio Pre and POst INTubation
An observational study of Acute Hypoxemic Respiratory Failure, run by Hospital Universitario de Gran Canaria Doctor Negrín at 2 sites in 2 countries.
Trial summary
We designed this study to dtermine whether invasive mechanical ventilation (MV) would have an impact on the reclassification of patients with acute hypoxemic respiratory failure (AHRF) -treated previously with non-invasive respiratory support- into categories of severity (mild, moderate, and severe). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 29 Apr 2023to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AHRF (defined as PaO2/FiO2 lower or equal to 300 mmHg and FiO2 greater or equal to 0.3, on non-invasive ventilatory support) prior to intubation.
Who may be able to join
- Patients meeting criteria for AHRF while they are on non-invasive respiratory support.
- We will only include patients who had arterial blood gases (ABG) within a time-frame of the last 5 hours of NIV and the first 5 hours of invasive MV.
- We will only include patients treated with high-flow oxygen nasal cannula (HFNC), or continuous positive airway pressure (CPAP), or bilevel positive pressure (BiPAP).
Who cannot join
- Patients who never required HFNC, or CPAP, or BiPAP before intubation.
- Patients with no ABG during the last 5 hours of NIV before intubation.
- Patients with no ABG during the first 5 hours after initiation of invasive MV.
- Patients treated with inhaled pulmonary vasodilator only before or only after intubation.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Assessment of PaO2/FiO2 Ratio Pre and POst INTubation (The APPOINT Study)
We designed this study to dtermine whether invasive mechanical ventilation (MV) would have an impact on the reclassification of patients with acute hypoxemic respiratory failure (AHRF) -treated previously with non-invasive respiratory support- into categories of severity (mild, moderate, and severe). Our hypothesis is that the assessment of PaO2/FiO2 ratio on PEEP greater or equal to 5 cmH2O after intubation, in patients labeled as mild/moderate/severe AHRF while on non-invasive respiratory support, would identify that a marked proportion of patients would change the degree of severity after a brief period of invasive MV
Read the detailed description
Current criteria for definition of the acute respiratory distress syndrome (AHRF) are inadequate for inclusion of patients into clinical trials due to: (i) the lack of standardization for measuring the oxygenation defect (as assessed by the PaO2/FiO2 ratio) and (ii) the inclusion of non-intubated patients into the mild category of severity. We questioned whether the PaO2/FiO2 (P/F) ratio calculated before endotracheal intubation in non-intubated patients who otherwise meet AHRF criteria, would still meet the severity threshold once patients are intubated.
We will examine at 24 after intubation and initiation of MV whether adult patients with AHRF remained in the same AHRF category of severity (mild, moderate, severe) or do not meet the PaO2/FiO2 criterion for AHRF. If our hypothesis is supported, it would suggest that stratification of patients labeled based on P/F ratio while treated with non-invasive respiratory support is of limited utility for testing specific therapies for AHRF in non-intubated patients.
This is a high quality screening, longitudinal, defined population, retrospective study.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- Mechanical ventilation
- Keywords
- acute respiratory failure, non-invasive ventilatory support, mechanical ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationDevice
Need for endotracheal intubation and invasive mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Patients on non-invasive ventilatory support to IMV | Patients with AHRF treated with non-invasive ventilatory support [for the purpose of this study we included High-flow nasal cannula (HFNC), continuous positive airway pressure (CPAP), and non-invasive ventilation (NIV)] who required endotracheal intubation and invasive mechical ventilation. Receives: Device: Mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the degree of lung severity
from severe/moderate to moderate/mild, from moderate/mild to mild after a brief period of invasive MV
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start29 Apr 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies 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
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center
- Responsible party
- Principal investigator, Jesus Villar, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Jesús Villar, Study chair, Hospital Universitario D. Negrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853068
- Sponsor's protocol ID
- 2022-161-1
- Acronym
- APPOINT
- Status last verified
- Aug 2025
- First submitted
- 2 May 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of PaO2/FiO2 Ratio Pre and POst INTubation (The APPOINT Study)
- ClinicalTrials.gov ID
- NCT05853068
- Acronym / sponsor ID
- APPOINT / 2022-161-1
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- acute respiratory failure, non-invasive ventilatory support, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Collaborators
- Rush University Medical Center
- Study start
- 29 Apr 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 10 May 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.
We designed this study to dtermine whether invasive mechanical ventilation (MV) would have an impact on the reclassification of patients with acute hypoxemic respiratory failure (AHRF) -treated previously with non-invasive respiratory support- into categories of severity (mild, moderate, and severe). Our hypothesis is that the assessment of PaO2/FiO2 ratio on PEEP greater or equal to 5 cmH2O after intubation, in patients labeled as mild/moderate/severe AHRF while on non-invasive respiratory support, would identify that a marked proportion of patients would change the degree of severity after a brief period of invasive MV
Detailed description
Current criteria for definition of the acute respiratory distress syndrome (AHRF) are inadequate for inclusion of patients into clinical trials due to: (i) the lack of standardization for measuring the oxygenation defect (as assessed by the PaO2/FiO2 ratio) and (ii) the inclusion of non-intubated patients into the mild category of severity. We questioned whether the PaO2/FiO2 (P/F) ratio calculated before endotracheal intubation in non-intubated patients who otherwise meet AHRF criteria, would still meet the severity threshold once patients are intubated.
We will examine at 24 after intubation and initiation of MV whether adult patients with AHRF remained in the same AHRF category of severity (mild, moderate, severe) or do not meet the PaO2/FiO2 criterion for AHRF. If our hypothesis is supported, it would suggest that stratification of patients labeled based on P/F ratio while treated with non-invasive respiratory support is of limited utility for testing specific therapies for AHRF in non-intubated patients.
This is a high quality screening, longitudinal, defined population, retrospective study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on non-invasive ventilatory support to IMV | – | Device: Mechanical ventilationPatients with AHRF treated with non-invasive ventilatory support [for the purpose of this study we included High-flow nasal cannula (HFNC), continuous positive airway pressure (CPAP), and non-invasive ventilation (NIV)] who required endotracheal intubation and invasive mechical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AHRF (defined as PaO2/FiO2 lower or equal to 300 mmHg and FiO2 greater or equal to 0.3, on non-invasive ventilatory support) prior to intubation.
Key inclusion criteria (3 listed)
- Patients meeting criteria for AHRF while they are on non-invasive respiratory support.
- We will only include patients who had arterial blood gases (ABG) within a time-frame of the last 5 hours of NIV and the first 5 hours of invasive MV.
- We will only include patients treated with high-flow oxygen nasal cannula (HFNC), or continuous positive airway pressure (CPAP), or bilevel positive pressure (BiPAP).
Key exclusion criteria (4 listed)
- Patients who never required HFNC, or CPAP, or BiPAP before intubation.
- Patients with no ABG during the last 5 hours of NIV before intubation.
- Patients with no ABG during the first 5 hours after initiation of invasive MV.
- Patients treated with inhaled pulmonary vasodilator only before or only after intubation.
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 |
|---|---|---|
| Mechanical ventilationNeed for endotracheal intubation and invasive mechanical ventilation | Device | Patients on non-invasive ventilatory support to IMV |
Primary outcome
Change in the degree of lung severity
Time frame: 60 days
from severe/moderate to moderate/mild, from moderate/mild to mild after a brief period of invasive MV
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Jesús Villar study chair
Hospital Universitario D. Negrin
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hypoxemic Respiratory Failure, run by Hospital Universitario de Gran Canaria Doctor Negrín at 2 sites in 2 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 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in the degree of lung severity (time frame: 60 days). 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 26 Aug 2025.