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

Sponsor
Universidad Autonoma de Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT04832828
Collaborator
(none)
114
1
5.9
19.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Roth´s Test

Study Design

Study Type:
Observational
Actual Enrollment :
114 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Sensitivity and Specificity of the Roth Test in Patients With COVID-19 Positive
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Nov 28, 2020
Actual Study Completion Date :
Nov 28, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Oxygen Saturation [12 weeks]

    The pulseoximeter percentage value

Secondary Outcome Measures

  1. Roth´s test [12 weeks]

    The level described in the test

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CS Entrevías Madrid Spain 28053

Sponsors and Collaborators

  • Universidad Autonoma de Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Raúl Ferrer-Peña, Principal investigator, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier:
NCT04832828
Other Study ID Numbers:
  • PI-4321
First Posted:
Apr 6, 2021
Last Update Posted:
Apr 6, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2021