Silent Hypoxia and Awake Proning in COVID-19 Patients

Not Applicable

Completed

• Conditions: Hypoxemia; Covid19
• Interventions: Other: Self measurement with pulse oximeter

• Registration Number: NCT04647747
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-11-27
• Study Start: 2020-11-30
• Study First Posted: 2020-12-01
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self measurement of peripheral saturation	Self measurement with pulse oximeter	Participant will be equipped with a pulse oximeter and perform saturation measurements.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ostfold Hospital; 🇳🇴 Sarpsborg, Grålum, Norway