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Not listed No phase listed Observational

Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS

ClinicalTrials.gov ID: NCT03546699

Public ClinicalTrials.gov record NCT03546699. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 3:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter Prospective Cohort Study of Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS - The NITWA ARDS Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03546699
Recruitment status
Not listed
Study type
Observational
Phase
Not listed
Enrollment
9,999 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 23, 2018
Primary completion
May 4, 2023
Completion
Oct 14, 2023
Last update posted
May 10, 2023

2018 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Beth Israel Deaconess Medical Center Boston Massachusetts 02215

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03546699, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 10, 2023 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03546699 live on ClinicalTrials.gov.

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