Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2025-12-17 @ 6:00 AM
Study NCT ID:
NCT04433039
Status:
None
Last Update Posted:
2020-06-16 00:00:00
First Post:
2020-06-14 00:00:00
Brief Title:
COVID19 Versus H1N1: Radiological Challenge During Next Influenza Season Rising
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
COVID-19 Versus H1N1 Viral Pneumonia: A Retrospective Comparative Study for Spectrum of HRCT Findings Among 130 Patients
Status:
None
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A. Study population and medical records review:
Inclusion criteria: 65 COVID-19 and 65 H1N1 patients to be enrolled. Exclusion criteria: (1) Degraded quality of CT scans due to patient unavoidable tachypnea with respiratory motion artifacts. (2) Unremarkable CT scans were also excluded. (3) Past history of large airway disease, asthma, COPD or bronchiectasis. (4) Patients with secondary bacterial infection.
B. CT scanning and parameters:
CT examinations conducted using multiple MDCT machines including: GE LightSpeed Plus 4 slice CT scanner (USA), Philips Brilliant-16 (USA), Siemens SOMATOM Emotion 16 and Siemens SOMATOM Sensation 64 (Germany), Toshiba Aquilion 64 and Toshiba Aquilion CXL/CX 128 (USA).
CT Scanning parameters : Slice thickness: 1 - 1.25 mm. Volumetric HRCT table speed with least cycles of breath holds as possible. Tube rotation: 0.6-0.9 second. Detector Collimation 1 mm. Helical mode (volumetric HRCT). kVp and mA per slice: 120 - 130 kVp and 200-400 mA, according to the type of MSCT machine used, the weight of the patient and the clinical indication.
C. CT analysis:
CT images to be assessed by three consultant radiologists (having long time experience in chest imaging). Image analysis in axial, sagittal and coronal planes done using both maximum intensity projection (MIP) and minimum intensity projection (Min-IP) reconstructions. The following CT features to be compared between each pathological process:
A. Site of the pathology: unilateral or bilateral - focal, multi-focal or diffuse.
B. Mosaic pattern; including ground glass opacities (GGO), mosaic perfusion, air trapping and "head cheese pattern".
C. Reticular pattern; including interlobular septal thickening, "crazy paving pattern", bronchial wall thickening, mucous plugging, traction bronchiectasis/bronchiolectasis and honeycombing.
D. Nodular pattern; including GG nodules and solid nodules; including solid nodules with "halo sign" and tree in bud nodules.
E. Relevant CT findings: including pleural, pericardial and nodal lesions.
D. Statistical analysis:
The prevalence of HRCT findings estimated as the percentage of patients showing each criteria or abnormality.
Inclusion criteria: 65 COVID-19 and 65 H1N1 patients to be enrolled. Exclusion criteria: (1) Degraded quality of CT scans due to patient unavoidable tachypnea with respiratory motion artifacts. (2) Unremarkable CT scans were also excluded. (3) Past history of large airway disease, asthma, COPD or bronchiectasis. (4) Patients with secondary bacterial infection.
B. CT scanning and parameters:
CT examinations conducted using multiple MDCT machines including: GE LightSpeed Plus 4 slice CT scanner (USA), Philips Brilliant-16 (USA), Siemens SOMATOM Emotion 16 and Siemens SOMATOM Sensation 64 (Germany), Toshiba Aquilion 64 and Toshiba Aquilion CXL/CX 128 (USA).
CT Scanning parameters : Slice thickness: 1 - 1.25 mm. Volumetric HRCT table speed with least cycles of breath holds as possible. Tube rotation: 0.6-0.9 second. Detector Collimation 1 mm. Helical mode (volumetric HRCT). kVp and mA per slice: 120 - 130 kVp and 200-400 mA, according to the type of MSCT machine used, the weight of the patient and the clinical indication.
C. CT analysis:
CT images to be assessed by three consultant radiologists (having long time experience in chest imaging). Image analysis in axial, sagittal and coronal planes done using both maximum intensity projection (MIP) and minimum intensity projection (Min-IP) reconstructions. The following CT features to be compared between each pathological process:
A. Site of the pathology: unilateral or bilateral - focal, multi-focal or diffuse.
B. Mosaic pattern; including ground glass opacities (GGO), mosaic perfusion, air trapping and "head cheese pattern".
C. Reticular pattern; including interlobular septal thickening, "crazy paving pattern", bronchial wall thickening, mucous plugging, traction bronchiectasis/bronchiolectasis and honeycombing.
D. Nodular pattern; including GG nodules and solid nodules; including solid nodules with "halo sign" and tree in bud nodules.
E. Relevant CT findings: including pleural, pericardial and nodal lesions.
D. Statistical analysis:
The prevalence of HRCT findings estimated as the percentage of patients showing each criteria or abnormality.
Detailed Description:
A Study population and medical records review
Inclusion criteria 65 COVID-19 and 65 H1N1 patients to be enrolled Exclusion criteria 1 Degraded quality of CT scans due to patient unavoidable tachypnea with respiratory motion artifacts 2 Unremarkable CT scans were also excluded 3 Past history of large airway disease asthma COPD or bronchiectasis 4 Patients with secondary bacterial infection
B CT scanning and parameters
CT examinations conducted using multiple MDCT machines including GE LightSpeed Plus 4 slice CT scanner USA Philips Brilliant-16 USA Siemens SOMATOM Emotion 16 and Siemens SOMATOM Sensation 64 Germany Toshiba Aquilion 64 and Toshiba Aquilion CXLCX 128 USA
CT Scanning parameters Slice thickness 1 - 125 mm Volumetric HRCT table speed with least cycles of breath holds as possible Tube rotation 06-09 second Detector Collimation 1 mm Helical mode volumetric HRCT kVp and mA per slice 120 - 130 kVp and 200-400 mA according to the type of MSCT machine used the weight of the patient and the clinical indication
C CT analysis
CT images to be assessed by three consultant radiologists having long time experience in chest imaging Image analysis in axial sagittal and coronal planes done using both maximum intensity projection MIP and minimum intensity projection Min-IP reconstructions The following CT features to be compared between each pathological process
A Site of the pathology unilateral or bilateral - focal multi-focal or diffuse
B Mosaic pattern including ground glass opacities GGO mosaic perfusion air trapping and head cheese pattern
C Reticular pattern including interlobular septal thickening crazy paving pattern bronchial wall thickening mucous plugging traction bronchiectasisbronchiolectasis and honeycombing
D Nodular pattern including GG nodules and solid nodules including solid nodules with halo sign and tree in bud nodules
E Relevant CT findings including pleural pericardial and nodal lesions
D Statistical analysis
The prevalence of HRCT findings estimated as the percentage of patients showing each criteria or abnormality
Inclusion criteria 65 COVID-19 and 65 H1N1 patients to be enrolled Exclusion criteria 1 Degraded quality of CT scans due to patient unavoidable tachypnea with respiratory motion artifacts 2 Unremarkable CT scans were also excluded 3 Past history of large airway disease asthma COPD or bronchiectasis 4 Patients with secondary bacterial infection
B CT scanning and parameters
CT examinations conducted using multiple MDCT machines including GE LightSpeed Plus 4 slice CT scanner USA Philips Brilliant-16 USA Siemens SOMATOM Emotion 16 and Siemens SOMATOM Sensation 64 Germany Toshiba Aquilion 64 and Toshiba Aquilion CXLCX 128 USA
CT Scanning parameters Slice thickness 1 - 125 mm Volumetric HRCT table speed with least cycles of breath holds as possible Tube rotation 06-09 second Detector Collimation 1 mm Helical mode volumetric HRCT kVp and mA per slice 120 - 130 kVp and 200-400 mA according to the type of MSCT machine used the weight of the patient and the clinical indication
C CT analysis
CT images to be assessed by three consultant radiologists having long time experience in chest imaging Image analysis in axial sagittal and coronal planes done using both maximum intensity projection MIP and minimum intensity projection Min-IP reconstructions The following CT features to be compared between each pathological process
A Site of the pathology unilateral or bilateral - focal multi-focal or diffuse
B Mosaic pattern including ground glass opacities GGO mosaic perfusion air trapping and head cheese pattern
C Reticular pattern including interlobular septal thickening crazy paving pattern bronchial wall thickening mucous plugging traction bronchiectasisbronchiolectasis and honeycombing
D Nodular pattern including GG nodules and solid nodules including solid nodules with halo sign and tree in bud nodules
E Relevant CT findings including pleural pericardial and nodal lesions
D Statistical analysis
The prevalence of HRCT findings estimated as the percentage of patients showing each criteria or abnormality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None