Associations Between COVID-19 ARDS Treatment, Clinical Trajectories and Liberation From Mechanical Ventilator - an Analysis of the NorthCARDS Dataset

Completed

Conditions studied: ARDS, Human, Covid19

In brief

The mortality rates associated with COVID-19 related ARDS (COVIDARDS) have varied from observational reports from around the world. This has ranged from 44% (28 day mortality) in the UK to 36% (28 day mortality from ICU admission) in Italian studies, to 32% (all-cause 28 day mortality) in Spain. Predictive models have identified risk factors for COVID-19 hospitalized patients' mortality to include male sex, obesity, age, obesity, comorbidities including chronic lung disease and hypertension, as well as biomarkers including high levels of D-Dimer, LDH and CRP. In addition, practice patterns, such as drugs that were administered, timing of mechanical ventilation and adherence to established lung protective ventilation protocols are known to be variable across sites and have changed over time. The investigators propose to analyze outcomes for patients with COVIDARDS within the NorthCARDS dataset (a dataset of over 1500 patients with COVID-19 related ARDS across the Northwell Health System in the NYC metropolitan region and Long Island, NY) to understand differences in hospital survival and in the time to liberation from mechanical ventilation, specifically looking at the associations between baseline patient factors, changes in biomarkers, respiratory function and hemodynamics over time, and treatments administered. The analyses will be based on three hypotheses: H.1. Worsening trajectories of: oxygenation index (OI), respiratory system compliance (C), and inflammatory markers will be associated with lower hospital survival. H.2. Higher duration of deep sedation and paralytics will be associated with greater time to liberation from mechanical ventilation. This risk will be increased in patients with worsening trajectories of OI, C, and inflammatory markers over time. H.3. Type of mechanical ventilator, specifically the time on portable mechanical ventilator, is associated with hospital mortality and with inability to liberate from mechanical ventilator despite controlling for risk factors of changes in OI, C and Inflammatory markers over time, and the use of paralytics and deep sedation.

Key facts

Study ID

NCT04729075

Run by

Northwell Health

People needed

1800

Starts

2021-01-19

Expected to finish

2021-01-19

Last updated by the study team

2023-04-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inpatients at any of the hospitals within the Northwell Health system
• COVID19 PCR positive
• meeting ARDS criteria (defined as)
• PaO2:FiO2 <300 for at least 2 consecutive values (including 2 S/F values)
• bilateral infiltrates
• mechanical ventilation (NIMV or IMV with PEEP 5)
• Timeframe March 1, 2020 until December 30, 2020

You may not qualify if…

• Patients admitted for surgical procedures
• infiltrates described as being due to cardiogenic pulmonary edema without COVID-19 pneumonia
• improvement of paO2:FiO2 to > 300 within 48 hours

Where it is running

• Feinstein Institutes for Medical Research — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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