Silent Hypoxia and Awake Proning in COVID-19 Patients (SHYCOV)

March 15, 2024 updated by: Hans Joakim Myklebust-Hansen, Ostfold Hospital Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Grålum
      • Sarpsborg, Grålum, Norway, 1714
        • Ostfold Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Self measurement of peripheral saturation
Participant will be equipped with a pulse oximeter and perform saturation measurements.
Other: Self measurement with pulse oximeter
Participant will measure peripheral saturation at home, conduct physiotherapy if desaturation occurs, and contact hospital if desatuation persists
Other Names:
  • Lung physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who manage to perform daily measurements of SpO2
Time Frame: January 30, 2021
January 30, 2021
Incidence rate of silent hypoxia in non-hospitalized COVID-19
Time Frame: January 30, 2021
January 30, 2021
Association between silent hypoxia and other subjective and objective measurements of disease severity
Time Frame: January 30, 2021
January 30, 2021

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of a self-managed physiotherapy program on alleviating hypoxia
Time Frame: January 30, 2021
January 30, 2021
Rate of persistent silent hypoxia episode per patients
Time Frame: January 30, 2021
January 30, 2021
Rate of silent hypoxia episode per patients
Time Frame: January 30, 2021
January 30, 2021
Rate of hospital admission and ICU admission
Time Frame: January 30, 2021
January 30, 2021
Incidence of thromboembolic event in outpatients diagnosed with COVID-19
Time Frame: January 30, 2021
January 30, 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ostfold Hospital Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2020

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

November 27, 2020

First Submitted That Met QC Criteria

November 27, 2020

First Posted (Actual)

December 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHYCOV2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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