Silent Hypoxia and Awake Proning in COVID-19 Patients

Covid19 Clinical Trial

— SHYCOV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647747
• Other study ID #: SHYCOV2020
• Status: Completed
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: March 2024
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Hypoxemia
• Hypoxia

Intervention

Other:
• Self measurement with pulse oximeter
Participant will measure peripheral saturation at home, conduct physiotherapy if desaturation occurs, and contact hospital if desatuation persists

Locations

Country	Name	City	State
Norway	Ostfold Hospital	Sarpsborg	Grålum

Sponsors (1)

Lead Sponsor	Collaborator
Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who manage to perform daily measurements of SpO2		January 30, 2021
Primary	Incidence rate of silent hypoxia in non-hospitalized COVID-19		January 30, 2021
Primary	Association between silent hypoxia and other subjective and objective measurements of disease severity		January 30, 2021
Secondary	Effect of a self-managed physiotherapy program on alleviating hypoxia		January 30, 2021
Secondary	Rate of persistent silent hypoxia episode per patients		January 30, 2021
Secondary	Rate of silent hypoxia episode per patients		January 30, 2021
Secondary	Rate of hospital admission and ICU admission		January 30, 2021
Secondary	Incidence of thromboembolic event in outpatients diagnosed with COVID-19		January 30, 2021