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

• Conditions: COVID-19

• Registration Number: NCT05490914
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

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.The SARS-CoV-2 (COVID-19) ARDS is an emerging novel devastating disease with high mortality. Distinct features 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 optimal ventilation strategies for COVID-19 ARDS need to be systematically studied. The overall purpose of this study is to investigate the prognostic indicators in COVID-19 ARDS patients.Specific Aim 1: To develop a REDcap database of clinical and biologic information in subjects with COVID-19, and to investigate the prognostic indicators compared with influenza and SARS ARDS patients.Specific Aim 2: To follow up the long-term change pulmonary function test of COVID ARDS patients using home-based personal pulmonary function test device

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Primary Completion: 2022-12-31
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Read More

Exclusion Criteria

1. Pregnancy
2. No consent/inability to obtain consent or appropriate legal representative not available

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome of the retrospective cohort	through study completion, an average of 1 year	ICU and in-hospital mortality

Secondary Outcome Measures

Name	Time	Method
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	forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan