Skip to main content
OpenTrials
Completed

NCT Number: NCT04647747

Silent Hypoxia and Awake Proning in COVID-19 Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Hypoxemia Hypoxia Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ostfold Hospital

Sarpsborg, Grålum, 1714, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self measurement with pulse oximeter

Other

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

Other names: Lung physiotherapy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Registry information

Official study title

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

Acronym: SHYCOV

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 1, 2020
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.