NCT04618835

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

October 31, 2020

Last Update Submit

February 23, 2021

Conditions

Covid19Medical Emergencies

Keywords

Exercise tolerance testVital signsReadmissionMortality

Outcome Measures

Primary Outcomes (3)

  • Change in decision to discharge

    1. No change 2. Further investigations 3. Hospital admission a) No change b) Further investigations c) Hospital admission

    24 hours

  • Hospital

    Admission to hospital within 30 days of the test

    30 days

  • Death

    Death within 30 days of the test

    30 days

Secondary Outcomes (5)

  • Feasibility of the 40-steps test

    12 months

  • Change in heart rate

    Within 2 minutes of completion of the test

  • Change in oxygen saturations

    Within 2 minutes of completion of the test

  • Change in respiratory rate

    Within 2 minutes of completion of the test

  • Change in breathlessness

    Within 2 minutes of completion of the test

Study Arms (1)

Emergency presentations

Patients discharged after a presentation to practitioners in the community, primary and secondary care.

Diagnostic Test: 40-Steps-test

Interventions

40-Steps-testDIAGNOSTIC_TEST

40 steps performed on the spot

Emergency presentations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All alert and mobile acutely ill patients with mild symptoms and little or no vital sign derangement being considered for discharge to independent care

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ysbyty Gwynedd

Menai Bridge, Gwynedd, LL57 2PW, United Kingdom

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Christian Subbe, DM

CONTACT

+447771922890csubbe@hotmail.com

Laura Langshaw

CONTACT

+441248384384laura.longshaw@wales.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Physician

Study Record Dates

First Submitted

October 31, 2020

First Posted

November 6, 2020

Study Start

January 11, 2021

Primary Completion

November 3, 2021

Study Completion

November 3, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)