Clincosm LogoSign in Get a demo

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

Sponsor
American University of Beirut Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03946189
Collaborator
(none)
150
Enrollment
1
Location
13.6
Actual Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Diagnostic Test: Obtaining arterial blood gases

Study Design

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 :
Mar 14, 2018
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm 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 Names:
  • 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 Names:
  • 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 Names:
  • No other intervention

    		•

    Outcome Measures

    Primary Outcome Measures

    1. New oxygenation index [Immediate]

      Oxygenation index that incorporates ventilator parameters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 American University of Beirut Beirut Lebanon

    Sponsors and Collaborators

    • American University of Beirut Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    American University of Beirut Medical Center
    ClinicalTrials.gov Identifier:
    NCT03946189
    Other Study ID Numbers:
    • BIO-2018-0033
    First Posted:
    May 10, 2019
    Last Update Posted:
    May 10, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Acute Lung Injury
    Syndrome

    Study Results

    No Results Posted as of May 10, 2019