Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS

We hypothesize that the hospital-wide incidence of ARDS, as defined by the Kigali
modification, is similar in high resource settings (e.g., Boston and Toronto) as compared to
the resource-constrained setting of Kigali, Rwanda. We also hypothesize that pulmonary
ultrasound is a more sensitive and similarly specific imaging modality for bilateral
opacities than chest radiograph, when compared to the reference standard of chest tomography.

We will test these hypotheses in a multicenter prospective cohort study with the following
specific aims:

Aim 1: A) To estimate the hospital-wide incidence of ARDS defined according to both the
Berlin definition and the Kigali modification, and B) To describe clinical characteristics
and outcomes for these patients.

Aim 2: 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.

As a part of the research study, we will perform a pilot study with the specific aim of
assessing feasibility of a multicenter study. Criteria that will be used to assess
feasibility include:

1. Number of hospitalised adult patients who fulfill Kigali or Berlin ARDS criteria over
the first 7 days post-hospital admission;

2. Number of hospitalised adult patients who develop hypoxemia as detected on daily
screening, during the first 7 days post-hospital admission (% hypoxemic patients/new
admissions);

3. Proportion of recruited patients/eligible patients (see below for eligibility criteria);

4. Work-load per patient (lung ultrasound scanning time; average data collection time on
the first day of hypoxemia);

5. Proportion of patients with CXR, CT scan and LUS available from the same +/-1 day.

All adults (≥ 18 years old) admitted to the hospital during either of two one-week study
periods (winter and summer) will be screened daily for hypoxemia (defined as oxygen
saturation < 90%) or use of any supplemental oxygen for a total of 7 days. For the initial
feasibility phase, both in-person and electronic administrative records screening will be
performed. Depending on the site and the results of the pilot phase, in the multicenter study
the screening will be accomplished using electronic administrative records or in-person
screening.

For any eligible patient who screens positive during the study period we will collect data as
detailed in the table below:

Day 1 post-hypoxemia detection

- Demographic characteristics (year of birth, sex, height, weight)

- Admission data (type of admission - elective/emergency; transfer vs direct admission vs
ED admission -; date of admission; if transfer from other hospital; ward - medicine,
surgery, ICU)

- Main diagnosis/clinical presentation

- Co-morbidities

- ARDS risk factors at admission

- New or worsening symptoms within 7 days

- Institution of mechanical ventilation (invasive or non-invasive)

- Oxygenation data

- Lung Ultrasound data

- CXR and CT scans occurring up to 24 hours before onset of hypoxemia

Day 2-6 post-hypoxemia detection

- Oxygenation data

- Lung Ultrasound data

- Chest imaging

Day 7 post-hypoxemia detection

- Etiology of hypoxemia (as determined by MRP)

- New ARDS risk factors identified

- Need for ICU admission first 7 days

- Institution of mechanical ventilation first 7 days (invasive and non-invasive)

- Oxygenation data

- Lung Ultrasound data

- Structured focused lung ultrasound

- Chest imaging

Outcome data collection

- Vital status at hospital separation, censored at 90 days

- Date of hospital discharge (or death)

- ICU admission and duration of ICU stay

For any eligible patient who does not screen positive during any day of the study period
(days 1-7 post hospital admission), we will collect the following data:

- Vital status at hospital separation, censored at 90 days

- Date of hospital discharge (or death)

- ICU admission and duration of ICU stay

For patients undergoing CT chest during the 7 days of data collection, we will attempt the
performance of an extra lung ultrasound examination immediately before or after the CT scan

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Patient in the Emergency Department but not formally admitted to the hospital

- Patient admitted in PACU