Respiratory Supports and COVID-19 Mortality

NCT04832061 | Completed

• 1 other identifier: 2000028070
• Study Type: observational
• Target: 2,300
• Locations: 1 country
• Sites: 1

Brief Summary

Critically ill COVID-19 patients have a relatively high mortality rate (\~30%). Most critically ill COVID-19 patients require respiratory supports. The respiratory supports used in this patient population included conventional oxygen therapy (COT) via nasal cannula or face mask, non-invasive ventilation (NIV), and invasive mechanical ventilation (IMV). NIV has three different methods, including high-flow nasal cannula (HFNC), bilevel positive airway pressure (BiPAP), and continuous positive airway pressure (CPAP). There are outstanding questions that remain to be answered. One is which NIV is more effective; the other is if the use of IMV leads to increased mortality. Another relevant question is if ventilator settings (such as tidal volume, drive pressure, and positive end-expiratory pressure) are associated with different mechanical ventilated patients' outcomes. To answer these questions, a retrospective cohort study based on all patients who had been treated in the ICUs in Yale New Haven Health System throughout the first pandemic year was designed.

Conditions

COVID-19

Keywords

COVID-19; respiratory support; non-invasive ventilation; invasive mechanical ventilation; effectiveness; mortality

Outcome Measures

Primary Outcomes (1)

• rate of in-hospital mortality

  the number of all-cause death during hospitalization divided by the number of patients who were discharged from hospital or remained hospitalized but alive on the last day of data extraction

  through study completion, an average of 11 days

Secondary Outcomes (1)

• rate of escalation from non-invasive ventilation to invasive mechanical ventilation

  through study completion, an average of 11 days

Interventions

Respiratory supports OTHER

The respiratory supports used in this patient population included conventional oxygen therapy (COT) via nasal cannula or face mask, non-invasive ventilation (NIV), and invasive mechanical ventilation (IMV). NIV has three different methods, including high-flow nasal cannula (HFNC), bilevel positive airway pressure (BiPAP), and continuous positive airway pressure (CPAP).

Eligibility Criteria

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

Study Population

All COVID-19 patients treated in the ICUs in Yale New Haven Health System throughout the first pandemic year

You may qualify if:

• All COVID-19 patients treated in the ICUs in Yale New Haven Health System throughout the first pandemic year

You may not qualify if:

• None

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Kimberly Kunze

  Yale University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 5, 2021
• Study Start: April 1, 2021
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)