COVID-19 Acute Respiratory Distress SyndromeNCT05682612
Prognostic Value of PtcO2 in Patients With COVID-19
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Southeast University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- outcome and Subtype of COVID-19
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19 patients
Who may be able to join
- 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)；
Who cannot join
- Pregnant or lactating women; Patients who refuse to undergo transcutaneous tissue oxygen pressure monitoring; Clinicians believe that patients are not appropriate; Patients undergoing ECMO.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda hospital
Nanjing, Jiangsu, 210000
Jingyyuan Xu, MD, 13851417209@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- outcome, Subtype of COVID-19
- Keywords
- ARDS, respiratory failure, COVID-19
- Medical subject headings
- Respiratory Insufficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outcomeOther
hospital survivors and nonsurvivors
Subtype of COVID-19Other
Different subtype of COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Survivors of COVID-19 induced respiratory failure Receives: Other: outcome; Other: Subtype of COVID-19 | |
| Nonsurvivors | Nonsurvivors of COVID-19 induced respiratory failure Receives: Other: outcome; Other: Subtype of COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Transcutaneous partial pressure of oxygen
Level of Transcutaneous partial pressure of oxygen
Measured: up to 30 days
Secondary outcomes (1)
Level of Transcutaneous partial pressure of oxygen/FiO2
Level of Transcutaneous partial pressure of oxygen/FiO2
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start9 Jan 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Jingyuan Xu, M.D., Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682612
- Sponsor's protocol ID
- 2023ZDSYLL001-P01
- Status last verified
- Oct 2023
- First submitted
- 1 Jan 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Transcutaneous Partial Pressure of Oxygen in Patients With Novel Coronavirus Infection
- ClinicalTrials.gov ID
- NCT05682612
- Acronym / sponsor ID
- 2023ZDSYLL001-P01
- Keywords
- ARDS, respiratory failure, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Other: outcome, Other: Subtype of COVID-19Survivors of COVID-19 induced respiratory failure |
| Nonsurvivors | – | Other: outcome, Other: Subtype of COVID-19Nonsurvivors of COVID-19 induced respiratory failure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patients
Key inclusion criteria (1 listed)
- 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)；
Key exclusion criteria (1 listed)
- Pregnant or lactating women; Patients who refuse to undergo transcutaneous tissue oxygen pressure monitoring; Clinicians believe that patients are not appropriate; Patients undergoing ECMO.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| outcomehospital survivors and nonsurvivors | Other | Nonsurvivors, Survivors |
| Subtype of COVID-19Different subtype of COVID-19 | Other | Nonsurvivors, Survivors |
Primary outcome
Level of Transcutaneous partial pressure of oxygen
Time frame: up to 30 days
Level of Transcutaneous partial pressure of oxygen
1 secondary outcome
Level of Transcutaneous partial pressure of oxygen/FiO2
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingyuan Xu, M.D. principal investigator
Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingyuan Xu, M.D. (008613851417209, 13851417209@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Transcutaneous partial pressure of oxygen (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.