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Silent Hypoxia and Awake Proning in COVID-19 Patients

Silent Hypoxia and Awake Proning in COVID-19 Patients: Home Monitoring and Self-Reporting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04647747
Acronym
SHYCOV
Enrollment
40
Registered
2020-12-01
Start date
2020-11-30
Completion date
2021-03-30
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Hypoxemia

Keywords

Silent Hypoxia, Lung Physiotherapy, Home Monitoring

Brief summary

The Investigators want to examine patients infected with SARS-CoV-2 for the phenomenon Silent Hypoxia, which is clinically significant hypoxia without corresponding degree of dyspnea. The patient population is infected individuals without any serious symptoms and is at home. The participants will be equipped with a pulse oximeter and a PEF-measurement device. Four times daily the participants will register saturation, degree of dyspnea and PEF. If the participants experience desaturation or increasing dyspnea, physiotherapy is to be performed, and if that doesn't relieve symptoms or increase oxygen saturation, the hospital should be contacted for admission. The first part of this study is a feasibility study, and if found feasible, the investigators will expand the study to more participants.

Interventions

OTHERSelf measurement with pulse oximeter

Participant will measure peripheral saturation at home, conduct physiotherapy if desaturation occurs, and contact hospital if desatuation persists

Sponsors

Ostfold Hospital Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Non dyspneic (NRS =/\< 1) patients with positive SARS-CoV-2 test * Age 18 - 80 years * Patients managed at home * Inclusion within 72 hours from positive test

Exclusion criteria

* Chronic hypoxia (SpO2 \< 93 %) and/or first measured SpO2 \< 93 % * Admitted to hospital for COVID-19 prior to inclusion * Unable to perform pulse oximetry * Unable to perform physiotherapy

Design outcomes

Primary

MeasureTime frame
Number of patients who manage to perform daily measurements of SpO2January 30, 2021
Incidence rate of silent hypoxia in non-hospitalized COVID-19January 30, 2021
Association between silent hypoxia and other subjective and objective measurements of disease severityJanuary 30, 2021

Secondary

MeasureTime frame
Rate of hospital admission and ICU admissionJanuary 30, 2021
Effect of a self-managed physiotherapy program on alleviating hypoxiaJanuary 30, 2021
Incidence of thromboembolic event in outpatients diagnosed with COVID-19January 30, 2021
Rate of persistent silent hypoxia episode per patientsJanuary 30, 2021
Rate of silent hypoxia episode per patientsJanuary 30, 2021

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026