NCT05077982

The Long Term Effects of COVID on Pulmonary Function

Long Term Outcomes of COVID-19 Critical Illness: Cohort Study of Adult Patients Admitted to the Intensive Care Unit at Mater Dei Hospital With COVID-19 Infection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 123 (actual)
• Sponsor: Sciberras, Stephen M.D. · Individual
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

An observational cohort study of patients discharged from the ICU following admission with COVID19 infection, looking at their medical wellbeing 6 months after discharge from the ICU.

Detailed description

The COVID-19 epidemic has placed an unprecedented strain on medical services worldwide. Throughout 2020 and early 2021, hospitals and their critical care services have been inundated with patients suffering from critical illness due to COVID-19, some of whom developed multi-organ failure and required a prolonged ICU stay. While the medical literature is now replete with publications and research on the acute phase of illness due to COVID-19, including critical illness, there is a paucity of studies detailing the long-term outcomes following COVID-19 critical illness. While the negative long-term physical health, mental health and quality-of-life related effects of ARDS have been well documented, there has been very little long-term COVID-19 ARDS specific outcome studies published. This is an observational cohort study that aims to assess the long-term health outcomes of adult patients admitted to Mater Dei Hospital Intensive Care Unit with COVID-19 infection. Patients will initially be assessed at 6 months after discharge from ITU. They will be interviewed by trained researchers using validated questionnaires. These questionnaires will assess their physical health, mental health and functional status. Participants will be examined and asked to do a 6minute walk test also using validated non-invasive physical assessment tools. They will be offered pulmonary function tests to be carried out at the Pulmonary function laboratory.

Conditions

• Covid19
• COVID-19 Pneumonia
• Critical Illness
• Quality of Life

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Spirometry	Spirometry to assess lung function
DIAGNOSTIC_TEST	6-minute walk	Exercise tolerance

Timeline

• Start date: 2021-10-15
• Primary completion: 2021-12-31
• Completion: 2022-01-31
• First posted: 2021-10-14
• Last updated: 2023-04-12

Locations

2 sites across 1 country: Malta