- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560530
The Role of CT Chest Scan in the Pre-anesthetic Assessment of Suspected or Confirmed COVID -19 Patients
The Use of Preoperative CT Chest Scan in the Pre-anesthetic Assessment of COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Riyadh, Saudi Arabia
- Security Forces Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pneumonia severity.
Time Frame: 90 days
|
The pneumonia severity will be assessed by the radiologist.
|
90 days
|
|
Aorta diameter
Time Frame: 90 days
|
Aorta cross sectional diameter will be calculated by using cursor method on CT scan
|
90 days
|
|
Pulmonary artery diameter
Time Frame: 90 days
|
Pulmonary artery sectional diameter will be calculated by using cursor method on CT scan
|
90 days
|
|
Pulmonary artery diameter TO Aorta diameter ratio
Time Frame: 90 days
|
Pulmonary artery diameter TO Aorta diameter ratio will be calculated
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Description of the lesions found in the CT scan
Time Frame: 90 days
|
The parenchymal lesions will be described by the radiologist
|
90 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- chest CT scan in COVID-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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