- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04298814
Safety Related Factors of Endotracheal Intubation in Patients With Severe Covid-19 Pneumonia
July 16, 2020 updated by: aijun xu, Tongji Hospital
Analysis of Safety Related Factors of Endotracheal Intubation in Patients With Severe Covid-19 Pneumonia
To analyze the intubation with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
To analyze the intubation time, intubation condition, intubation process, intubation times and success rate of patients with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, the degree of respiratory improvement and survival rate of patients, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.
Study Type
Observational
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
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Tongji Hospital
-
-
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 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Severe and critical patients with covid-19 pneumonia in urgent need of tracheal intubation
Description
Inclusion Criteria:
- Wuhan residents;
- novel coronavirus pneumonia was found to be characterized by fever and cough. Laboratory tests revealed leukocyte or lymphocyte decrease, chest CT examination showed viral pneumonia changes, and was diagnosed as COVID-19 pneumonia according to the national health and Health Committee's new coronavirus pneumonia diagnosis and treatment plan (trial version fifth Revision).
- Severe and critical patients with covid-19 pneumonia in urgent need of tracheal intubation;
- Sign informed consent.
Exclusion Criteria:
- Suspected patients with covid-19 pneumonia;
- Patients who need emergency endotracheal intubation due to other causes of respiratory failure;
- The family refused to sign the informed consent.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate of intubation
Time Frame: the time span between 1hour before intubation and 24h after intubation
|
The data of Success rate of intubation with severe COVID-19 pneumonia patients
|
the time span between 1hour before intubation and 24h after intubation
|
Infection rate of Anesthesiologist
Time Frame: the time span between 1hour before intubation and 14days after intubation
|
Infection rate of Anesthesiologist who performed the endotracheal intubation for severe COVID-19 pneumonia patients
|
the time span between 1hour before intubation and 14days after intubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extubation time
Time Frame: the time span between 1hour before intubation and 30days after intubation
|
Extubation time of intubated severe COVID-19 pneumonia patients
|
the time span between 1hour before intubation and 30days after intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 7, 2020
Primary Completion (ANTICIPATED)
December 30, 2020
Study Completion (ANTICIPATED)
December 30, 2020
Study Registration Dates
First Submitted
February 26, 2020
First Submitted That Met QC Criteria
March 4, 2020
First Posted (ACTUAL)
March 6, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 20, 2020
Last Update Submitted That Met QC Criteria
July 16, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVEI
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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