COVID-19NCT04298814
Safety Related Factors of Endotracheal Intubation in Patients With Severe Covid-19 Pneumonia
An observational study of COVID-19 and Endotracheal Intubation, run by Tongji Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19, Endotracheal Intubation
- What is being tested?
- severe covid-19 pneumonia with ET
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2020to 30 Dec 2020
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe and critical patients with covid-19 pneumonia in urgent need of tracheal intubation
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Endotracheal Intubation
- Being tested
- severe covid-19 pneumonia with ET
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
severe covid-19 pneumonia with ETOther
severe covid-19 pneumonia undergoing endotracheal intubation
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of intubation
The data of Success rate of intubation with severe COVID-19 pneumonia patients
Measured: the time span between 1hour before intubation and 24h after intubation
Infection rate of Anesthesiologist
Infection rate of Anesthesiologist who performed the endotracheal intubation for severe COVID-19 pneumonia patients
Measured: the time span between 1hour before intubation and 14days after intubation
Secondary outcomes (1)
Extubation time
Extubation time of intubated severe COVID-19 pneumonia patients
Measured: the time span between 1hour before intubation and 30days after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start7 Aug 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Why it stopped: It was repeated with other studies in the same department
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- Aijun XU, Dr., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298814
- Sponsor's protocol ID
- COVEI
- Status last verified
- Jul 2020
- First submitted
- 26 Feb 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Safety Related Factors of Endotracheal Intubation in Patients With Severe Covid-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04298814
- Acronym / sponsor ID
- COVEI
- Conditions
- COVID-19, Endotracheal Intubation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: It was repeated with other studies in the same department
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 7 Aug 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 6 Mar 2020 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe and critical patients with covid-19 pneumonia in urgent need of tracheal intubation
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| severe covid-19 pneumonia with ETsevere covid-19 pneumonia undergoing endotracheal intubation | Other | – |
Primary outcome
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
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
1 secondary outcome
Extubation time
Time frame: the time span between 1hour before intubation and 30days after intubation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
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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.
Aijun XU, Dr. principal investigator
Tongji Hospital
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 and Endotracheal Intubation, run by Tongji Hospital 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 20 Jul 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of intubation (time frame: the time span between 1hour before intubation and 24h after intubation). The study lists 2 primary outcomes in all. 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 20 Jul 2020.