Prognostic Value of PtcO2 in Patients With COVID-19

October 9, 2023 updated by: Jingyuan,Xu, Southeast University, China

Prognostic Value of Transcutaneous Partial Pressure of Oxygen in Patients With Novel Coronavirus Infection

Five percent of patients with COVID-19 progressed to respiratory failure and required ICU admission, such patients often have abnormal oxygen tolerance. However, there is still a lack of clinical indicators to predict the prognosis and treatment responsiveness of COVID-19.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Five percent of patients with COVID-19 progressed to respiratory failure and required ICU admission. Attention should be paid to patients over 65 years of age who have severe underlying diseases (cancer, respiratory diseases, cardiovascular and cerebrovascular diseases, chronic renal failure, autoimmune deficiency diseases, etc.) and have not completed the whole course of vaccine, and such patients often have abnormal oxygen tolerance, that is, a significant decrease in skin finger pulse oxygen saturation (SpO2) can occur after daily activities. Basal SpO2 at admission is often associated with prognosis, but it is difficult to differentiate prognosis from responsiveness to treatment by changes in SpO2 after oxygen therapy is administered clinically. However, there is still a lack of clinical indicators to predict the prognosis and treatment responsiveness of COVID-19.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COVID-19 patients

Description

Inclusion Criteria:

  • Age: 18-80 years, male or female; Patients with COVID-9 pneumonia (typical imaging features of COVID-19 pneumonia) (oxygen saturation ≤ 93% during air or arterial partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) ≤ 300 mmHg at rest)；

Exclusion Criteria:

  • Pregnant or lactating women; Patients who refuse to undergo transcutaneous tissue oxygen pressure monitoring; Clinicians believe that patients are not appropriate; Patients undergoing ECMO.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Survivors
Survivors of COVID-19 induced respiratory failure
Other: outcome
hospital survivors and nonsurvivors
Other: Subtype of COVID-19
Different subtype of COVID-19
Nonsurvivors
Nonsurvivors of COVID-19 induced respiratory failure
Other: outcome
hospital survivors and nonsurvivors
Other: Subtype of COVID-19
Different subtype of COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Transcutaneous partial pressure of oxygen
Time Frame: up to 30 days
Level of Transcutaneous partial pressure of oxygen
up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Transcutaneous partial pressure of oxygen/FiO2
Time Frame: up to 30 days
Level of Transcutaneous partial pressure of oxygen/FiO2
up to 30 days

Collaborators and Investigators

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

Sponsor

Southeast University, China

Investigators

  • Principal Investigator: Jingyuan Xu, M.D., Southeast university

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)

January 9, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

January 1, 2023

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023ZDSYLL001-P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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