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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date February 2021
Source Betsi Cadwaladr University Health Board
Contact Christian Subbe, DM
Phone +447771922890
Email csubbe@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
40-Steps-test
40 steps performed on the spot

Locations

Country Name City State
United Kingdom Ysbyty Gwynedd Menai Bridge Gwynedd

Sponsors (2)

Lead Sponsor Collaborator
Betsi Cadwaladr University Health Board Oxford Brookes University

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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