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Recruiting
NCT05095090
Study of Hospitalised Patients With Acute Respiratory Conditions
Conditions: Acute Respiratory Disease, COPD Exacerbation Acute, Asthma, Pneumonia
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: Yes
Enrollment: 500
Sponsor: University of Leicester
Location: Glenfield Hospital Leicester
Summary
The goal of this observational study is to learn about the short- and long-term outcomes of people admitted to hospital with an acute respiratory condition, including exacerbations of chronic lung disease, and to understand factors that may predict recovery, hospital readmission, length of hospital stay, and mortality. A group of people with chronic respiratory disease who are being followed in respiratory outpatient clinics and a healthy control group without lung disease will also take part.
The main questions it aims to answer are:
* Which clinical, physical, functional, and biological characteristics are associated with short-term outcomes after hospitalisation, including 30-day hospital readmission, length of hospital stay, and 30-day mortality?
* Which characteristics are associated with longer-term recovery, future exacerbations, hospital readmissions, healthcare use, and mortality?
* Can measurements taken during or around the time of hospitalisation be used to identify people at greater risk of poor outcomes who may benefit from targeted interventions?
Participants will undergo clinical assessments that may include questionnaires, measurements of physical function and muscle strength, lung function tests, physical activity monitoring, and collection of biological samples. Some participants may also undergo additional assessments of body composition, muscle size and function, imaging, or muscle metabolism, including through nested sub-studies. Participants will be followed for up to 36 months to assess recovery and longer-term clinical outcomes.
Eligibility Criteria
Inclusion Criteria (Core study participants)
1. Hospital admission with an acute respiratory diagnosis, or currently under the care of hospital respiratory outpatient services for a chronic respiratory disease
2. Participant is willing \& able to give informed consent for participation in the study
3. Aged 18 years or above
4. Able (in the Investigators opinion) \& willing to comply with all study requirements
Exclusion Criteria (Core study participants)
1. Unstable or life-threatening cardiac disease including myocardial infarction or unstable angina during current admission.
2. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
3. Known pregnancy
Inclusion Criteria (Healthy Controls)
1. Aged 18 years or above
2. No underlying respiratory disease as self-reported
3. Able (in the Investigators opinion) \& willing to comply with all study requirements
Exclusion Criteria (Healthy Controls)
1. Hospitalised due to an acute respiratory illness in the last 6 weeks prior to consent
2. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
3. Known pregnancy
Additional inclusion and exclusion criteria for CHESTY sub-studies are detailed in the corresponding sub-study protocols.
Source: ClinicalTrials.gov (NCT05095090). StuddyBuddy aggregates publicly available trial information.