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Mar. 15, 2019

Jan. 01, 2022

jRCTs022180006

Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector. Application 1 in emergency area: For pulmonary embolism patients. (Clinical application of chest x-ray dynamic photography)

Clinical application of chest x-ray dynamic photography (Clinical application of chest x-ray dynamic photography)

Jan. 01, 2022

4

The average age is 73 years (70-76). Three had a definitive diagnosis of pulmonary embolus (all males), and the remaining one was a suspected case (female).

Registration was successful at the beginning, but due to the COVID-19 epidemic, the target number of cases was 150, but case registration did not proceed at all and the study was discontinued.. The registration of 4 cases is in 2019. In addition, there were 5 cases in which consent was not reached during the period.

No harmful events occurred.

Case registration did not proceed and neither the primary nor secondary evaluation could be sufficiently evaluated. In the analysis of 4 cases, In all cases, CT showed embolism (1 of which was bilateral), and 5 area of 4 cases (100%) were able to visually confirm decreased blood flow. This is 100% sensitive, although the number of cases is small. On the other hand, decreased blood flow on the healthy side, which is not an embolic lung, was not visually observed in all cases (3 cases). That is, the specificity was also 100%. Visual judgment was made by 3 people.

The number of cases was small and could not be evaluated sufficiently. The sensitivity and specificity was 100% in the analysis of 4 cases.

Jan. 01, 2022

No

No plan

https://jrct.mhlw.go.jp/latest-detail/jRCTs022180006

SHIMADA JIRO

Fukushima Medical University Hospital

1 Hikarigaoka, Fukushima City, Fukushima, JAPAN

+81-24-547-1111

jshimada@fmu.ac.jp

SHIMADA JIRO

Fukushima Medical University Hospital

1 Hikarigaoka, Fukushima City, Fukushima, JAPAN

+81-24-547-1111

jshimada@fmu.ac.jp

Complete

Oct. 01, 2018

Sept. 14, 2018
150

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

diagnostic purpose

1) Be an adult over 20 years old
2) Written informed consent
3) Patients suspected of pulmonary embolism or patients diagnosed with pulmonary embolism
4) Chest CT contrast test scheduled for diagnosis or follow-up of pulmonary embolism

1) have allergy to the contrast agent
2) During pregnancy, possibility of pregnancy, delivery within 28 days, breast-feeding
3) Psychiatric disorder or psychiatric symptoms are merged and it is judged difficult to participate in the trial
4) Severe cases (during artificial respiration, SpO2 <93% even when administered oxygen, wearing an extracorporeal circulation assisting device, shock index> 1, during noradrenaline administration, GCS <13)
5) Even if it does not apply to 4) above, the patient who judged treatment as priority by the attending physician

20age old over
No limit

Both

pulmonary embolism

chest X-ray dynamics photographing

Sensitivity for diagnosis of pulmonary embolism in measurement method of heart rate variation of permeability of 18 lung fields by chest X-ray dynamic imaging apparatus with contrast CT examination as a reference

Specificity for diagnosis of pulmonary embolism in measurement method of heart rate variation of permeability of 18 lung fields by chest X-ray dynamic imaging apparatus with contrast CT examination as a reference
Sensitivity and specificity of pulmonary embolism diagnosis of blood flow mapping image by chest x-ray dynamic imaging device

KONICA MINOLTA, CO., Ltd
Applicable
KONICA MINOLTA, CO., Ltd
Applicable
Fukushima Medical University Certified Review Board
1 Hikarigaoka, Fukushima city, Hukushima

+81-24-547-1825

fmucrb@fmu.ac.jp
Approval

Jan. 16, 2019

UMIN000033644
Clinical application of chest x-ray dynamic photography 1

none

History of Changes

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5 Jan. 01, 2022 (this page) Changes
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3 Mar. 12, 2021 Detail Changes
2 Aug. 25, 2020 Detail Changes
1 Mar. 15, 2019 Detail