The Prognostic Factors of COVID-19 ARDS Patients and Their Long-term Follow-up of Pulmonary Function Test

NCT05490914 | Unknown

• 1 other identifier: 202005059RIND
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an emerging infectious disease with high transmissibility. Around 20-25% of infected individuals develop severe COVID-19 disease requiring hospitalization and 5-8% require intubation secondary to viral pneumonia and acute respiratory distress syndrome (ARDS). Distinct features of COVID-19 ARDS were found since Nov 2019, including relatively normal lung mechanics, activation of the RAAS system, selective injury of type II alveolar cells, and presence of vasodilation vessel and micro-thrombosis. The mechanism, potential useful biomarker, and the optimal ventilation strategies for COVID-19 ARDS need to be systematically studied. This study hypothesized that the low-tidal volume ventilation strategy is effective in COVID-19 ARDS. We will retrospectively review the clinical presentation, epidemiologic data, laboratory and image examination, medication use, lung mechanics、serum biomarker, long-term pulmonary function test, and clinical outcomes in COVID-19 ARDS, influenza ARDS, and SARS ARDS patients. We will also prospectively monitor the lung function of COVID ARDS patients using personal pulmonary function devices after discharge from NTUH. The overall purpose of this study is to investigate the prognostic indicators of COVID ARDS patients and their long-term pulmonary function follow-up.

Conditions

COVID-19

Keywords

COVID-19; ARDS; Lung mechanics; Ventilation strategy; Lung mechanics&function

Outcome Measures

Primary Outcomes (2)

• Primary Outcome of the retrospective cohort

  liberation from mechanical ventilation/ventilator dependency on ventilation day 28

  on ventilation day 28

• Primary Outcome of the retrospective cohort

  ICU and in-hospital mortality

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Outcome of the prospective cohort: pulmonary function test will be performed daily by the patients after discharge from NTUH

  through study completion, an average of 1 year

Study Arms (2)

Experimental Group

COVID-19 case

Control Group

Healthy population without COVID-19

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Experimental Group：COVID-19 case Control Group：Healthy population without COVID-19

You may qualify if:

• Adult \>20 years old
• Retrospective cohort by medical chart review：COVID-19 patients, Influenza patients, and SARS patients at NTUH
• Prospective cohort：COVID-19 confirmed patients intubated and receiving mechanical ventilation \> 24 hours at NTUH, got extubated and discharged

You may not qualify if:

• Pregnancy
• No consent/inability to obtain consent or appropriate legal representative not available

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

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

• Chin-Chung Shu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: August 8, 2022
• Study Start: July 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: February 15, 2023

Record last verified: 2022-04

Locations

TW (1)