NCT04647747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

November 27, 2020

Last Update Submit

March 15, 2024

Conditions

Covid19Hypoxemia

Keywords

Silent HypoxiaLung PhysiotherapyHome Monitoring

Outcome Measures

Primary Outcomes (3)

  • 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

  • Association between silent hypoxia and other subjective and objective measurements of disease severity

    January 30, 2021

Secondary Outcomes (5)

  • Effect of a self-managed physiotherapy program on alleviating hypoxia

    January 30, 2021

  • Rate of persistent silent hypoxia episode per patients

    January 30, 2021

  • Rate of silent hypoxia episode per patients

    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

Study Arms (1)

Self measurement of peripheral saturation

OTHER

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

Other: Self measurement with pulse oximeter

Interventions

Self measurement with pulse oximeterOTHER

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

Also known as: Lung physiotherapy
Self measurement of peripheral saturation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non dyspneic (NRS =/\< 1) patients with positive SARS-CoV-2 test
  • Age 18 - 80 years
  • Patients managed at home

You may not qualify if:

  • Chronic hypoxia (SpO2 \< 93 %) and/or first measured SpO2 \< 93 %
  • Unable to perform pulse oximetry
  • Unable to perform physiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ostfold Hospital

Sarpsborg, Grålum, 1714, Norway

Location

Related Publications (1)

  • Myklebust-Hansen HJ, Hasvik E, Solyga VM, Ghanima W. The feasibility of self-performing measurements of peripheral oxygen saturation and respiratory exercises in home-isolated COVID-19 patients-a single-arm prospective trial. Pilot Feasibility Stud. 2023 Dec 2;9(1):195. doi: 10.1186/s40814-023-01415-x.

    PMID: 38042811DERIVED

MeSH Terms

Conditions

COVID-19Hypoxia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Konstituert Overlege, Akuttseksjonen

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 1, 2020

Study Start

November 30, 2020

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)