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Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS

NCT03546699 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 9999

Last updated 2023-05-11

No results posted yet for this study

Summary

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).

Conditions

Interventions

DIAGNOSTIC_TEST

Estimation of hospital-wide incidence of ARDS

Estimation of hospital-wide incidence of ARDS defined according to both the Berlin definition and the Kigali modification. * To describe clinical characteristics and outcomes for these patients. * To analyze the prognosis and time course of patients who initially meet criteria for Kigali-defined ARDS and subsequently progress to Berlin-defined ARDS. For the subset of patients who have chest CT, to determine the sensitivity and specificity for bilateral opacities of both chest radiographs and chest ultrasound done within 12 hours as compared to the reference standard CT scans.

Sponsors & Collaborators

Principal Investigators

  • Alberto Goffi, MD · University Health Network, Toronto

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2023-05-05
Completion
2023-10-15

Countries

  • United States
  • Canada
  • Italy

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03546699 on ClinicalTrials.gov