Prognostic Value of PtcO2 in Patients With COVID-19

Sponsor

Southeast University, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05682612

Collaborator

(none)

Enrollment

Location

11.7

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Acute Respiratory Distress Syndrome	Other: outcome Other: Subtype of COVID-19

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 Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 9, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Transcutaneous oxygen [up to 30 days]
Transcutaneous partial pressure of oxygen

Secondary Outcome Measures

COVID-19 subtype [up to 30 days]
COVID-19 subtype

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.