NCT03946189

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

May 9, 2019

Last Update Submit

May 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • New oxygenation index

    Oxygenation index that incorporates ventilator parameters

    Immediate

Study Arms (3)

P/F less than 100

Patients receiving mechanical ventilation with paO2/FiO2 less than 100

Diagnostic Test: Obtaining arterial blood gases

P/F between 100 and 200

Patients receiving mechanical ventilation with paO2/FiO2 between 100 and 200

Diagnostic Test: Obtaining arterial blood gases

P/F between 200-300

Patients receiving mechanical ventilation with paO2/FiO2 between 200 and 300

Diagnostic Test: Obtaining arterial blood gases

Interventions

Obtaining arterial blood sample

Also known as: No other intervention
P/F between 100 and 200P/F between 200-300P/F less than 100

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of both gender and greater than 18 years old receiving mechanical ventilation in the ICU

You may qualify if:

  • Patients receiving mechanical ventilation in the Intensive Care Unit.
  • Patients in whom the managing medical team requested an arterial blood gas (ABG) analysis.

You may not qualify if:

  • Patients in whom arterial blood gas could not be obtained or not ordered.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut

Beirut, Lebanon

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 10, 2019

Study Start

March 14, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 10, 2019

Record last verified: 2019-05

Locations