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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05077982
Enrollment
123
Registered
2021-10-14
Start date
2021-10-15
Completion date
2022-01-31
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Covid19, Critical Illness

Brief 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.

Interventions

DIAGNOSTIC_TESTSpirometry

Spirometry to assess lung function

DIAGNOSTIC_TEST6-minute walk

Exercise tolerance

Sponsors

Mater Dei Hospital, Malta
CollaboratorOTHER
Sciberras, Stephen M.D.
Lead SponsorINDIV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* All patients admitted to the Intensive Care Unit with organ failure secondary to acute COVID-19 infection and successfully discharged from Mater Dei Hospital and surviving beyond 6 months after discharge, will be offered inclusion in the study. A positive COVID PCR result before or during the patient's admission will be necessary for inclusion in the study. Participants will be over 18 years of age, with no restriction as regards race, ethnicity or gender.

Exclusion criteria

* There are no

Design outcomes

Primary

MeasureTime frameDescription
Long term general health effects of critical illness due to COVID-19 infectionat 6 monthsObservation of the effect critical illness due to COVID-19 has on a patients' health related quality of life at 6 and 12 months after discharge from the ICU

Secondary

MeasureTime frameDescription
Correlation between severity of COVID19 illness and QOLat 6 monthsObservation of how different severity of critical illness secondary to COVID-19 infection correlates with medium and long-term health related quality of life outcomes.

Countries

Malta

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026