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The Observational Study of Cardiac and Pulmonary Ultrasound and Evaluation of Treatment of Severe Patients With Novel Coronavirus Pneumonia

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ClinicalTrials.gov Identifier: NCT04314271
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief Summary:
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.

Condition or disease
Novel Coronavirus Pneumonia

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Weeks
Official Title: The Observational Study of Cardiac and Pulmonary Ultrasound and Evaluation of Treatment of Severe Patients With Novel Coronavirus Pneumonia
Estimated Study Start Date : March 20, 2020
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 31, 2020





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult (Age ≥ 18 years) patients with novel coronavirus pneumonia
Criteria

Inclusion Criteria:

  1. age >18 years old
  2. identify the patients infected with novel coronavirus pneumonia;
  3. the patient completed CT examination;
  4. sign the informed consent.

Exclusion Criteria:

  1. age < 18;
  2. those who cannot complete cardiopulmonary ultrasound according to the a-ccue process;
  3. the patient or his guardian requests to withdraw from the researcher;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314271


Contacts
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Contact: Zhao Ch Guang, MD +86136673520046 562122649@qq.com

Locations
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China, Hunan
Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China, 410000
Contact: Xiao       xyyyllwyh@126.com   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
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Study Chair: Zhang Li Na, MD Xiangya Hospital
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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT04314271    
Other Study ID Numbers: 202003028
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases