Covid19NCT04560530
The Role of CT Chest Scan in the Pre-anesthetic Assessment of Suspected or Confirmed COVID -19 Patients
An observational study of Covid19, run by Tanta University at 1 site in Saudi Arabia.
Trial summary
The role of CT scan of the chest in Pre-anesthetic assessment of the severity of COVID-19 and the correlations between CT measurements of the aortic and pulmonary arteries diameters and severity of pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Non-enhanced CT scan of the chest
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Mar 2020to 1 Sep 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients who are older than 18 years, having confirmed or suspected COVID-19 infection and scheduled for emergency surgery.
Who may be able to join
- All patients scheduled for emergency surgery with symptoms suggestive of COVID-19 infection.
Who cannot join
- Pregnancy.
- Haemodynamic instability (Mean arterial blood pressure above 65 mmHg or the need for of inotropic drugs to maintain mean arterial blood pressure above 65 mmHg).
- Active bleeding.
- Any indication by the surgeon or the anesthesiologist to proceed for immediate surgery for the patient safety.
- Patients refusal to do CT scanning.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Preoperative CT Chest Scan in the Pre-anesthetic Assessment of COVID-19
The role of CT scan of the chest in Pre-anesthetic assessment of the severity of COVID-19 and the correlations between CT measurements of the aortic and pulmonary arteries diameters and severity of pneumonia.
Read the detailed description
Patients who were scheduled for emergency surgery during COVID-19 pandemic should have be screened for COVID pre-operatively given the prevalence f asymptomatic or mildly symptomatic cases that could be carriers to infection and possibly cause cross infection to the operating room staff especially the anesthetists who deal with the upper airway during intubation with high possibility of getting infected with SARS-COV 2 virus. Waiting respiratory tract PCR (RT-PCR) test for COVID can delay the surgery which may increase patients morbidity and mortality. RT-PCR test has limited sensitivity and specificity.
Patients who are confirmed to have COVID-19 infection (have positive RT-PCR) or patients who have possible COVID-19 infection (have symptoms but were not tested with RT-PCR) will undergo non-enhanced CT scanning of the chest (without giving IV contrast).
Chest CT scan will be interpreted by 2 Consultants radiologists with an experience of at least 10 years in their field.
The radiologists are going to be requested to comment on the lung parenchyma, describing the findings , assess the pulmonary artery, aorta diameters and the aorta:pulmonary diameters ratio will be then calculated. The degree of pneumonia severity index will then be described as well.
The radiologists will be blinded to the aim of the study.
All data will be collected and then correlation between the data sets will be statistically tested.
- Conditions
- Covid19
- Being tested
- Non-enhanced CT scan of the chest
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-enhanced CT scan of the chestRadiation
Non-enhanced CT scan of the chest with multi-slice CT scan machine.
What is being measured
The primary outcome is the main question the study is designed to answer.
pneumonia severity.
The pneumonia severity will be assessed by the radiologist.
Measured: 90 days
Aorta diameter
Aorta cross sectional diameter will be calculated by using cursor method on CT scan
Measured: 90 days
Pulmonary artery diameter
Pulmonary artery sectional diameter will be calculated by using cursor method on CT scan
Measured: 90 days
Pulmonary artery diameter TO Aorta diameter ratio
Pulmonary artery diameter TO Aorta diameter ratio will be calculated
Measured: 90 days
Secondary outcomes (1)
Description of the lesions found in the CT scan
The parenchymal lesions will be described by the radiologist
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Mar 2020
- Primary completion30 Jul 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMMED FAWZI ALI ABOSAMAK, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560530
- Sponsor's protocol ID
- chest CT scan in COVID-19
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 23 Sep 2020
- 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 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Preoperative CT Chest Scan in the Pre-anesthetic Assessment of COVID-19
- ClinicalTrials.gov ID
- NCT04560530
- Acronym / sponsor ID
- chest CT scan in COVID-19
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 23 Sep 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.
The role of CT scan of the chest in Pre-anesthetic assessment of the severity of COVID-19 and the correlations between CT measurements of the aortic and pulmonary arteries diameters and severity of pneumonia.
Detailed description
Patients who were scheduled for emergency surgery during COVID-19 pandemic should have be screened for COVID pre-operatively given the prevalence f asymptomatic or mildly symptomatic cases that could be carriers to infection and possibly cause cross infection to the operating room staff especially the anesthetists who deal with the upper airway during intubation with high possibility of getting infected with SARS-COV 2 virus. Waiting respiratory tract PCR (RT-PCR) test for COVID can delay the surgery which may increase patients morbidity and mortality. RT-PCR test has limited sensitivity and specificity.
Patients who are confirmed to have COVID-19 infection (have positive RT-PCR) or patients who have possible COVID-19 infection (have symptoms but were not tested with RT-PCR) will undergo non-enhanced CT scanning of the chest (without giving IV contrast).
Chest CT scan will be interpreted by 2 Consultants radiologists with an experience of at least 10 years in their field.
The radiologists are going to be requested to comment on the lung parenchyma, describing the findings , assess the pulmonary artery, aorta diameters and the aorta:pulmonary diameters ratio will be then calculated. The degree of pneumonia severity index will then be described as well.
The radiologists will be blinded to the aim of the study.
All data will be collected and then correlation between the data sets will be statistically tested.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are older than 18 years, having confirmed or suspected COVID-19 infection and scheduled for emergency surgery.
Key inclusion criteria (1 listed)
- All patients scheduled for emergency surgery with symptoms suggestive of COVID-19 infection.
Key exclusion criteria (5 listed)
- Pregnancy.
- Haemodynamic instability (Mean arterial blood pressure above 65 mmHg or the need for of inotropic drugs to maintain mean arterial blood pressure above 65 mmHg).
- Active bleeding.
- Any indication by the surgeon or the anesthesiologist to proceed for immediate surgery for the patient safety.
- Patients refusal to do CT scanning.
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 |
|---|---|---|
| Non-enhanced CT scan of the chestNon-enhanced CT scan of the chest with multi-slice CT scan machine. | Radiation | – |
Primary outcome
pneumonia severity.
Time frame: 90 days
The pneumonia severity will be assessed by the radiologist.
Aorta diameter
Time frame: 90 days
Aorta cross sectional diameter will be calculated by using cursor method on CT scan
Pulmonary artery diameter
Time frame: 90 days
Pulmonary artery sectional diameter will be calculated by using cursor method on CT scan
Pulmonary artery diameter TO Aorta diameter ratio
Time frame: 90 days
Pulmonary artery diameter TO Aorta diameter ratio will be calculated
1 secondary outcome
Description of the lesions found in the CT scan
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19, run by Tanta University at 1 site in Saudi Arabia.
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 5 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: finished, as of the sponsor's last update on 23 Sep 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 Saudi Arabia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pneumonia severity. (time frame: 90 days). The study lists 4 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 23 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.