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

NCT04729075 | Completed

• 1 other identifier: 19-0598
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ARDS, Human; Covid19

Outcome Measures

Primary Outcomes (2)

• Index Hospital Survival

  Through duration of hospital stay for up to 1 year

  up to 1 year

• Time to Mechanical Ventilator Liberation

  Censored at 6-months of follow-up; Liberation from mechanical ventilation will be defined as non-palliative extubation and persistent extubation for greater than one week.

  6 months

Secondary Outcomes (1)

• Hospital Readmission

  6 months

Interventions

ARDS and COVID19 treatments OTHER

Interventions that will be analyzed will include: immunomodulation; oxygen supplementation type, duration and level; mechanical ventilation type, duration; diuresis; inotrope/vasopressors; prone positioning

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID-19 ARDS patients receiving mechanical ventilation

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

Sponsors & Collaborators

• Northwell Health: lead
• BioSymetrics: collaborator
• Feinstein Institute for Medical Research: collaborator

Study Sites (1)

Feinstein Institutes for Medical Research

Manhasset, New York, 11030, United States

Location

Related Publications (1)

• Cheyne H, Gandomi A, Hosseini Vajargah S, Catterson VM, Mackoy T, McCullagh L, Musso G, Hajizadeh N. Drivers of mortality in COVID ARDS depend on patient sub-type. Comput Biol Med. 2023 Nov;166:107483. doi: 10.1016/j.compbiomed.2023.107483. Epub 2023 Sep 16.

  PMID: 37748219 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Negin Hajizadeh, MD, MPH

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 28, 2021
• Study Start: January 19, 2021
• Primary Completion: January 19, 2021
• Study Completion: January 19, 2021
• Last Updated: April 4, 2023

Record last verified: 2023-03

Locations

US (1)