Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS

Status unconfirmed

Conditions studied: ARDS, Respiratory Failure, Lung Ultrasound

In brief

The Acute Respiratory Distress Syndrome (ARDS) impacts one of every four patients requiring mechanical ventilation for respiratory support and carries a mortality rate of 40%. To diagnose ARDS, doctors currently use the Berlin definition, that requires chest radiographs and analysis of oxygenation in the blood (arterial blood gas). These tests are not available in areas of the world with constrained resources and may be unnecessarily invasive. A modification of the Berlin definition, using ultrasound and pulse oximetry (a small device that measures oxygen level non-invasively by clipping to the body, typically a finger), has been recently developed and tested in Kigali, Rwanda. This study will try to confirm the validity of the Kigali modification initially in Boston and Toronto and subsequently in other hospitals worldwide. If confirmed, this new definition could allow for faster recognition and potentially improved treatment of patients with ARDS and facilitate studies worldwide. The purposes of this study are: 1. To describe clinical characteristics and outcomes of patients diagnosed with ARDS according to the Berlin and Kigali definitions; 2. To determine how well chest radiograph and ultrasound of the chest are able to define ARDS, in comparison to chest computer tomography (CT).

Key facts

Study ID

NCT03546699

Run by

University Health Network, Toronto

People needed

9999

Starts

2018-10-24

Expected to finish

2023-10-15

Last updated by the study team

2023-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hospital admission during the study period
• Age ≥ 18 years old
• New onset of hypoxemia (SpO2 < 90% or use of any supplemental oxygen) or, for patients on home O2 treatment, higher than baseline O2 flow needed during the first 7 days of hospitalization.

You may not qualify if…

• Patient in the Emergency Department but not formally admitted to the hospital
• Patient admitted in PACU

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University Health Network — Toronto, Ontario, Canada
• AOU Citta' della Salute e Della Scienza - Molinette — Torino, Italy
• Ospedale San Giovanni Bosco — Torino, Italy

Full record on ClinicalTrials.gov

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