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

Primary Purpose

Covid19, Hypoxemia

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Self measurement with pulse oximeter
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring Silent Hypoxia, Lung Physiotherapy, Home Monitoring

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ostfold HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Self measurement of peripheral saturation

Arm Description

Participant will be equipped with a pulse oximeter and perform saturation measurements.

Outcomes

Primary Outcome Measures

Number of patients who manage to perform daily measurements of SpO2
Incidence rate of silent hypoxia in non-hospitalized COVID-19
Association between silent hypoxia and other subjective and objective measurements of disease severity

Secondary Outcome Measures

Effect of a self-managed physiotherapy program on alleviating hypoxia
Rate of persistent silent hypoxia episode per patients
Rate of silent hypoxia episode per patients
Rate of hospital admission and ICU admission
Incidence of thromboembolic event in outpatients diagnosed with COVID-19

Full Information

First Posted
November 27, 2020
Last Updated
February 3, 2021
Sponsor
Ostfold Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04647747
Brief Title
Silent Hypoxia and Awake Proning in COVID-19 Patients
Acronym
SHYCOV
Official Title
Silent Hypoxia and Awake Proning in COVID-19 Patients: Home Monitoring and Self-Reporting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ostfold Hospital Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Hypoxemia
Keywords
Silent Hypoxia, Lung Physiotherapy, Home Monitoring

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self measurement of peripheral saturation
Arm Type
Other
Arm Description
Participant will be equipped with a pulse oximeter and perform saturation measurements.
Intervention Type
Other
Intervention Name(s)
Self measurement with pulse oximeter
Other Intervention Name(s)
Lung physiotherapy
Intervention Description
Participant will measure peripheral saturation at home, conduct physiotherapy if desaturation occurs, and contact hospital if desatuation persists
Primary Outcome Measure Information:
Title
Number of patients who manage to perform daily measurements of SpO2
Time Frame
January 30, 2021
Title
Incidence rate of silent hypoxia in non-hospitalized COVID-19
Time Frame
January 30, 2021
Title
Association between silent hypoxia and other subjective and objective measurements of disease severity
Time Frame
January 30, 2021
Secondary Outcome Measure Information:
Title
Effect of a self-managed physiotherapy program on alleviating hypoxia
Time Frame
January 30, 2021
Title
Rate of persistent silent hypoxia episode per patients
Time Frame
January 30, 2021
Title
Rate of silent hypoxia episode per patients
Time Frame
January 30, 2021
Title
Rate of hospital admission and ICU admission
Time Frame
January 30, 2021
Title
Incidence of thromboembolic event in outpatients diagnosed with COVID-19
Time Frame
January 30, 2021

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ostfold Hospital
City
Sarpsborg
State/Province
Grålum
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Joakim Myklebust-Hansen, MD
Phone
004797501765
Email
hans.joakim.hansen@so-hf.no

12. IPD Sharing Statement

Plan to Share IPD
No

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Silent Hypoxia and Awake Proning in COVID-19 Patients

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