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

  • Lebanon
      • 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
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

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.

Sponsor

American University of Beirut Medical Center

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.

General Publications

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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