- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03946189
Comparison of the PaO2/FiO2 Ratio to Other Oxygenation Indexes for the Classification of Severity of Acute Respiratory Distress Syndrome
May 9, 2019 updated by: American University of Beirut Medical Center
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beirut, Lebanon
- American University of Beirut
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients of both gender and greater than 18 years old receiving mechanical ventilation in the ICU
Description
Inclusion Criteria:
- Patients receiving mechanical ventilation in the Intensive Care Unit.
- Patients in whom the managing medical team requested an arterial blood gas (ABG) analysis.
Exclusion Criteria:
- Patients in whom arterial blood gas could not be obtained or not ordered.
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 |
---|---|
P/F less than 100
Patients receiving mechanical ventilation with paO2/FiO2 less than 100
|
Obtaining arterial blood sample
Other Names:
|
P/F between 100 and 200
Patients receiving mechanical ventilation with paO2/FiO2 between 100 and 200
|
Obtaining arterial blood sample
Other Names:
|
P/F between 200-300
Patients receiving mechanical ventilation with paO2/FiO2 between 200 and 300
|
Obtaining arterial blood sample
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
New oxygenation index
Time Frame: Immediate
|
Oxygenation index that incorporates ventilator parameters
|
Immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
March 14, 2018
Primary Completion (Actual)
May 1, 2019
Study Completion (Actual)
May 1, 2019
Study Registration Dates
First Submitted
May 9, 2019
First Submitted That Met QC Criteria
May 9, 2019
First Posted (Actual)
May 10, 2019
Study Record Updates
Last Update Posted (Actual)
May 10, 2019
Last Update Submitted That Met QC Criteria
May 9, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIO-2018-0033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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