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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04560530
Other study ID # chest CT scan in COVID-19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date September 1, 2020

Study information

Verified date September 2020
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date September 1, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients scheduled for emergency surgery with symptoms suggestive of COVID-19 infection.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Non-enhanced CT scan of the chest
Non-enhanced CT scan of the chest with multi-slice CT scan machine.

Locations

Country Name City State
Saudi Arabia Security Forces Hospital Riyadh

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary pneumonia severity. The pneumonia severity will be assessed by the radiologist. 90 days
Primary Aorta diameter Aorta cross sectional diameter will be calculated by using cursor method on CT scan 90 days
Primary Pulmonary artery diameter Pulmonary artery sectional diameter will be calculated by using cursor method on CT scan 90 days
Primary Pulmonary artery diameter TO Aorta diameter ratio Pulmonary artery diameter TO Aorta diameter ratio will be calculated 90 days
Secondary Description of the lesions found in the CT scan The parenchymal lesions will be described by the radiologist 90 days
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