Sensitivity and Specificity of the Roth Test in Patients With COVID-19 Positive

April 3, 2021 updated by: Raúl Ferrer-Peña, Universidad Autonoma de Madrid
The presence of the described silent hypoxia in subjects diagnosed with COVID19 highlights the need for valid tools to assess respiratory capacity. The Roth test has been associated with acceptable sensitivity and specificity criteria in patients with previous respiratory pathology; however, its validity in this type of patient has not been proven.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28053
        • CS Entrevías

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects aged 18 to 90 years were recruited by non-probabilistic convenience sampling in Primary Health Care Centres of the Primary Health Care Management of SERMAS and the Intensive Care Unit of the University Hospital of Gran Canaria Doctor Negrín of the Canary Health Service

Description

Inclusion Criteria:

  1. having been diagnosed as COVID-19 positive and with symptoms compatible with Sars-Cov-2 infection in the last 7 days prior to assessment,
  2. having an understanding of Spanish,
  3. and having no history of respiratory pathology prior to the current infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID+ Group
Patients diagnosed with Covid19 positive in last 7 days
Diagnostic test: Roth´s Test
Subjets must count from 1 to 30 in their languages, and health professional will count seconds that last in take breath during the count.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Saturation
Time Frame: 12 weeks
The pulseoximeter percentage value
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roth´s test
Time Frame: 12 weeks
The level described in the test
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

November 28, 2020

Study Completion (Actual)

November 28, 2020

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

April 3, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 3, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-4321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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