Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS

NCT03546699 | Unknown

• 1 other identifier: LUS01_2018
• Study Type: observational
• Target: 9,999
• Locations: 3 countries
• Sites: 4

Brief 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. 1.To describe clinical characteristics and outcomes of patients diagnosed with ARDS according to the Berlin and Kigali definitions;
2. 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

ARDS; Respiratory Failure; Lung Ultrasound

Outcome Measures

Primary Outcomes (1)

• Hospital-wide incidence of ARDS

  ARDS incidence will be calculated as the number of patients fulfilling ARDS (Berlin or Kigali) during the first first 7 days of hospital admission divided by the total adult hospital admissions during the study period.

  Up to 7 days

Secondary Outcomes (1)

• 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

  Over the first 7 days of admission

Interventions

Estimation of hospital-wide incidence of ARDS DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adults admitted to the hospital during either of two one-week study periods (winter and summer)

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (4)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University Health Network

Toronto, Ontario, M5T2S8, Canada

Location

AOU Citta' della Salute e Della Scienza - Molinette

Torino, Italy

Location

Ospedale San Giovanni Bosco

Torino, Italy

Location

Related Publications (1)

• Riviello ED, Kiviri W, Twagirumugabe T, Mueller A, Banner-Goodspeed VM, Officer L, Novack V, Mutumwinka M, Talmor DS, Fowler RA. Hospital Incidence and Outcomes of the Acute Respiratory Distress Syndrome Using the Kigali Modification of the Berlin Definition. Am J Respir Crit Care Med. 2016 Jan 1;193(1):52-9. doi: 10.1164/rccm.201503-0584OC.

  PMID: 26352116 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Alberto Goffi, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 6, 2018
• Study Start: October 24, 2018
• Primary Completion: May 5, 2023
• Study Completion: October 15, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

IT (2); CA (1); US (1)