Acute Respiratory Distress SyndromeNCT03946189
Comparison of the PaO2/FiO2 Ratio to Other Oxygenation Indexes for the Classification of Severity of Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
In mechanically ventilated patients the PaO2/FiO2 ratio might not be the best reflection of the severity of ARDS. It does not incorporate variables and settings used during mechanical ventilatory support such as the positive end expiratory pressure (PEEP), inspiratory time to expiratory time ratio (Ti:Te), and the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Obtaining arterial blood gases
- How many people
- 150 participants
- Where
- 1 siteLebanon
- Study dates
- 14 Mar 2018to 1 May 2019
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Patients of both gender and greater than 18 years old receiving mechanical ventilation in the ICU
Who may be able to join
- Patients receiving mechanical ventilation in the Intensive Care Unit.
- Patients in whom the managing medical team requested an arterial blood gas (ABG) analysis.
Who cannot join
- Patients in whom arterial blood gas could not be obtained or not ordered.
Trial locations and contacts
1 site in 1 country.
About this study
In mechanically ventilated patients the PaO2/FiO2 ratio might not be the best reflection of the severity of ARDS. It does not incorporate variables and settings used during mechanical ventilatory support such as the positive end expiratory pressure (PEEP), inspiratory time to expiratory time ratio (Ti:Te), and the peak alveolar pressure (Palv). The aim is to identify a new oxygenation index for stratification of severity of ARDS
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Obtaining arterial blood gases
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obtaining arterial blood gasesDiagnostic test
Also called No other intervention
Obtaining arterial blood sample
| Study group | Role | What they receive |
|---|---|---|
| P/F less than 100 | Patients receiving mechanical ventilation with paO2/FiO2 less than 100 Receives: Diagnostic Test: Obtaining arterial blood gases | |
| P/F between 100 and 200 | Patients receiving mechanical ventilation with paO2/FiO2 between 100 and 200 Receives: Diagnostic Test: Obtaining arterial blood gases | |
| P/F between 200-300 | Patients receiving mechanical ventilation with paO2/FiO2 between 200 and 300 Receives: Diagnostic Test: Obtaining arterial blood gases |
What is being measured
The primary outcome is the main question the study is designed to answer.
New oxygenation index
Oxygenation index that incorporates ventilator parameters
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start14 Mar 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946189
- Sponsor's protocol ID
- BIO-2018-0033
- Status last verified
- May 2019
- First submitted
- 9 May 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El-Khatib MF, Bouakl IJ, Ayoub CM, Chatburn RL, Farhat H, Msheik M, Fakih MH, Hallal AH. Comparison of the Oxygenation Factor and the Oxygenation Ratio in Subjects With ARDS. Respir Care. 2020 Dec;65(12):1874-1882. doi: 10.4187/respcare.07669. Epub 2020 Jul 21.
PubMed 32694182
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the PaO2/FiO2 Ratio to Other Oxygenation Indexes for the Classification of Severity of Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03946189
- Acronym / sponsor ID
- BIO-2018-0033
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 10 May 2019 (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.
In mechanically ventilated patients the PaO2/FiO2 ratio might not be the best reflection of the severity of ARDS. It does not incorporate variables and settings used during mechanical ventilatory support such as the positive end expiratory pressure (PEEP), inspiratory time to expiratory time ratio (Ti:Te), and the peak alveolar pressure (Palv). The aim is to identify a new oxygenation index for stratification of severity of ARDS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P/F less than 100 | – | Diagnostic Test: Obtaining arterial blood gasesPatients receiving mechanical ventilation with paO2/FiO2 less than 100 |
| P/F between 100 and 200 | – | Diagnostic Test: Obtaining arterial blood gasesPatients receiving mechanical ventilation with paO2/FiO2 between 100 and 200 |
| P/F between 200-300 | – | Diagnostic Test: Obtaining arterial blood gasesPatients receiving mechanical ventilation with paO2/FiO2 between 200 and 300 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of both gender and greater than 18 years old receiving mechanical ventilation in the ICU
Key inclusion criteria (2 listed)
- Patients receiving mechanical ventilation in the Intensive Care Unit.
- Patients in whom the managing medical team requested an arterial blood gas (ABG) analysis.
Key exclusion criteria (1 listed)
- Patients in whom arterial blood gas could not be obtained or not ordered.
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 |
|---|---|---|
| Obtaining arterial blood gasesAlso: No other interventionObtaining arterial blood sample | Diagnostic test | P/F between 100 and 200, P/F between 200-300, P/F less than 100 |
Primary outcome
New oxygenation index
Time frame: Immediate
Oxygenation index that incorporates ventilator parameters
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 10 May 2019.
- Derived from this study: PubMed 32694182El-Khatib MF, Bouakl IJ, Ayoub CM, Chatburn RL, Farhat H, Msheik M, Fakih MH, Hallal AH. Comparison of the Oxygenation Factor and the Oxygenation Ratio in Subjects With ARDS. Respir Care. 2020 Dec;65(12):1874-1882. doi: 10.4187/respcare.07669. Epub 2020 Jul 21.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 2 inclusion and 1 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 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. 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?
New oxygenation index (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03946189, which also lists 1 linked publication.
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 10 May 2019.