NCT03546699|Unknown
Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS
A Multicenter Prospective Cohort Study of Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS - The NITWA ARDS Study
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A Multicenter Prospective Cohort Study of Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS - The NITWA ARDS Study
Sponsor study identifier
observational
9,999
3 countries
4
Study Start
October 24, 2018
Actual (reported)Primary Completion
May 5, 2023
Actual (reported)Study Completion
October 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 17, 2018
Actual (reported)June 6, 2018
Actual (reported)October 24, 2018
Actual (reported)May 5, 2023
Actual (reported)October 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All adults admitted to the hospital during either of two one-week study periods (winter and summer)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University Health Network
Toronto, Ontario, M5T2S8, Canada
AOU Citta' della Salute e Della Scienza - Molinette
Torino, Italy
Ospedale San Giovanni Bosco
Torino, Italy
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.
Alberto Goffi, MD
University Health Network, Toronto
First Submitted
May 17, 2018
First Posted
June 6, 2018
Study Start
October 24, 2018
Actual (reported)Primary Completion
May 5, 2023
Actual (reported)Tenecteplase in Patients With COVID-19
Contact the study team to confirm eligibility.
Study Completion
October 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 11, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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