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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04647747
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : February 4, 2021
Information provided by (Responsible Party):
Hans Joakim Myklebust-Hansen, Ostfold Hospital Trust

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.

Condition or disease Intervention/treatment Phase
Covid19 Hypoxemia Other: Self measurement with pulse oximeter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Silent Hypoxia and Awake Proning in COVID-19 Patients: Home Monitoring and Self-Reporting
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
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 Name: Lung physiotherapy

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

Secondary Outcome Measures :
  1. Effect of a self-managed physiotherapy program on alleviating hypoxia [ Time Frame: January 30, 2021 ]
  2. Rate of persistent silent hypoxia episode per patients [ Time Frame: January 30, 2021 ]
  3. Rate of silent hypoxia episode per patients [ Time Frame: January 30, 2021 ]
  4. Rate of hospital admission and ICU admission [ Time Frame: January 30, 2021 ]
  5. Incidence of thromboembolic event in outpatients diagnosed with COVID-19 [ Time Frame: January 30, 2021 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04647747

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Ostfold Hospital Recruiting
Sarpsborg, Grålum, Norway, 1714
Contact: Hans Joakim Myklebust-Hansen, MD    004797501765   
Sponsors and Collaborators
Ostfold Hospital Trust
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Responsible Party: Hans Joakim Myklebust-Hansen, Konstituert Overlege, Akuttseksjonen, Ostfold Hospital Trust Identifier: NCT04647747    
Other Study ID Numbers: SHYCOV2020
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hans Joakim Myklebust-Hansen, Ostfold Hospital Trust:
Silent Hypoxia
Lung Physiotherapy
Home Monitoring
Additional relevant MeSH terms:
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Signs and Symptoms, Respiratory