Covid19 Clinical Trial
Official title:
Exertional Desaturation as a Marker of Risk - Validation Study for the 40-steps-test; A Multi-centre Prospective Observational Cohort Study
NCT number | NCT04618835 |
Other study ID # | 283998 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 11, 2021 |
Est. completion date | November 3, 2021 |
Exertional desaturation is a feature of COVID-19. The study will measure vital signs of patients discharge by practitioners in primary care, secondary care or by paramedic practitioners. Patients will then undertake a 40-steps on the spot walk followed by measurements of heart rate and oxygen saturations for up to two minutes. Association of desaturation with 30 days hospital admission and mortality will be reported.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | November 3, 2021 |
Est. primary completion date | November 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients are being considered for discharge to independent care - Participant is willing and able to give informed consent for participation in the study. - Patient with independent, stable, gait - Patient is alert, attentive, coherent, and calm - Male or Female, aged 18 years or above. Exclusion Criteria: - Minor injuries - Elective surgery patients - Post-operative patients at discharge - Requires supplemental oxygen - Shortness of breath at rest (i.e. Borg or Numerical Rating Scale >=2) - Unstable angina - Patients on long-term-oxygen therapy - Pregnancy as stated by patient - Oxygen saturations < 95% on room air - Resting heart rate > 100 bpm - Resting respiratory rate > 25 bpm - ECG with signs of acute ischemia in patients where an ECG has been requested by the treating clinician - National Early Warning Score of 5 or more - Nursing home residents, or those being transferred to a nursing home or similar care facility |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Ysbyty Gwynedd | Menai Bridge | Gwynedd |
Lead Sponsor | Collaborator |
---|---|
Betsi Cadwaladr University Health Board | Oxford Brookes University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in decision to discharge | No change
Further investigations Hospital admission a) No change b) Further investigations c) Hospital admission |
24 hours | |
Primary | Hospital | Admission to hospital within 30 days of the test | 30 days | |
Primary | Death | Death within 30 days of the test | 30 days | |
Secondary | Feasibility of the 40-steps test | Proportion of sites and patients able to undertake the test | 12 months | |
Secondary | Change in heart rate | Change in heart rate compared to value measured before expercise | Within 2 minutes of completion of the test | |
Secondary | Change in oxygen saturations | Change in heart rate compared to value measured before exercise | Within 2 minutes of completion of the test | |
Secondary | Change in respiratory rate | Change in respiratory rate compared to value measured before exercise | Within 2 minutes of completion of the test | |
Secondary | Change in breathlessness | Change in breathlessness compared to value measured before exercise | Within 2 minutes of completion of the test |
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