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Comparison of the PaO2/FiO2 Ratio to Other Oxygenation Indexes for the Classification of Severity of Acute Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT03946189
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
American University of Beirut Medical Center

Brief 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 peak alveolar pressure (Palv). The aim is to identify a new oxygenation index for stratification of severity of ARDS

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Diagnostic Test: Obtaining arterial blood gases

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of the PaO2/FiO2 Ratio to Other Oxygenation Indexes for the Classification of Severity of Acute Respiratory Distress Syndrome
Actual Study Start Date : March 14, 2018
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019


Group/Cohort Intervention/treatment
P/F less than 100
Patients receiving mechanical ventilation with paO2/FiO2 less than 100
Diagnostic Test: Obtaining arterial blood gases
Obtaining arterial blood sample
Other Name: No other intervention

P/F between 100 and 200
Patients receiving mechanical ventilation with paO2/FiO2 between 100 and 200
Diagnostic Test: Obtaining arterial blood gases
Obtaining arterial blood sample
Other Name: No other intervention

P/F between 200-300
Patients receiving mechanical ventilation with paO2/FiO2 between 200 and 300
Diagnostic Test: Obtaining arterial blood gases
Obtaining arterial blood sample
Other Name: No other intervention




Primary Outcome Measures :
  1. New oxygenation index [ Time Frame: Immediate ]
    Oxygenation index that incorporates ventilator parameters



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946189


Locations
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Lebanon
American University of Beirut
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03946189    
Other Study ID Numbers: BIO-2018-0033
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury