Spirometry
Diagnostic TestSpirometry to assess lung function
NCT Number: NCT05077982
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.
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Notify Me18 year–95 year
All sexes
Observational
Mater Dei Hospital, Msida, Malta
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Spirometry to assess lung function
Exercise tolerance
Time frame: at 6 months
Observation 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
Time frame: at 12 months
Observation 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
Time frame: at 6 months
Observation of how different severity of critical illness secondary to COVID-19 infection correlates with medium and long-term health related quality of life outcomes.
Time frame: at 12 months
Observation of how different severity of critical illness secondary to COVID-19 infection correlates with medium and long-term health related quality of life outcomes.
Sciberras, Stephen M.D.
Indiv
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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