Silent Hypoxia and Awake Proning in COVID-19 Patients

NCT ID: NCT04647747

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2021-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 Hypoxemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Self measurement of peripheral saturation

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

Group Type OTHER

Self measurement with pulse oximeter

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Self measurement with pulse oximeter

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lung physiotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ostfold Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hans Joakim Myklebust-Hansen

Konstituert Overlege, Akuttseksjonen

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ostfold Hospital

Sarpsborg, Grålum, Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38042811 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SHYCOV2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.