- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04314271
The Observational Study of Cardiac and Pulmonary Ultrasound and Evaluation of Treatment of Severe Patients With Novel Coronavirus Pneumonia
March 16, 2020 updated by: Xiangya Hospital of Central South University
Complete the examination of cardio-pulmonary ultrasound in accordance with the a-ccue process of patients with novel coronavirus bedside.
To summarize and analyze the characteristics of cardiopulmonary ultrasound in patients with novel coronavirus pneumonia, and assess the relationship between pulmonary ultrasound imaging score and National Early Warning Score(NEWS) and prognosis.
Auto line B is a method which is based on artificial intelligence is used to calculate the lungs ultrasonic B line numbers reviewing the status of patients with lung, and also evaluate patients' lungs using the traditional artificial semi-quantitative method, to evaluate those two kinds of evaluation methods for the evaluation of patients with lung condition effects are consistent or not, and verify consistency of ultrasonic evaluation method and the way of CT evaluation.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
80
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
-
-
Hunan
-
Changsha, Hunan, China, 410000
- Recruiting
- Xiangya Hospital, Central South University
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult (Age ≥ 18 years) patients with novel coronavirus pneumonia
Description
Inclusion Criteria:
- age >18 years old
- identify the patients infected with novel coronavirus pneumonia;
- the patient completed CT examination;
- sign the informed consent.
Exclusion Criteria:
- age < 18;
- those who cannot complete cardiopulmonary ultrasound according to the a-ccue process;
- the patient or his guardian requests to withdraw from the researcher;
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: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
characteristics of cardiopulmonary ultrasound
Time Frame: 30 mins
|
Complete the examination of cardio-pulmonary ultrasound in accordance with the a-ccue process of patients with novel coronavirus bedside.
To summarize and analyze the characteristics of cardiopulmonary ultrasound in patients with novel coronavirus pneumonia
|
30 mins
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assess the relationship between pulmonary ultrasound imaging score and National Early Warning Score(NEWS) and prognosis.
Time Frame: 2-3weeks
|
assess the relationship between pulmonary ultrasound imaging score and National Early Warning Score(NEWS) and prognosis.
|
2-3weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluate two kinds of evaluation methods for the evaluation of patients with lung condition effects are consistent or not, and verify consistency of ultrasonic evaluation method and the way of CT evaluation.
Time Frame: 3 hours
|
Auto line B is a method which is based on artificial intelligence is used to calculate the lungs ultrasonic B line numbers reviewing the status of patients with lung, and also evaluate patients' lungs using the traditional artificial semi-quantitative method, to evaluate those two kinds of evaluation methods for the evaluation of patients with lung condition effects are consistent or not
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Zhang Li Na, MD, Xiangya Hospital
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 (Anticipated)
March 20, 2020
Primary Completion (Anticipated)
May 1, 2020
Study Completion (Anticipated)
May 31, 2020
Study Registration Dates
First Submitted
March 16, 2020
First Submitted That Met QC Criteria
March 16, 2020
First Posted (Actual)
March 19, 2020
Study Record Updates
Last Update Posted (Actual)
March 19, 2020
Last Update Submitted That Met QC Criteria
March 16, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202003028
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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