Comparison of Lung Function Based on Electrical Impedance Tomography and CT Lung Volume in Patients With Rib Fractures
EIT
1 other identifier
interventional
60
1 country
1
Brief Summary
Our research uses the electrical impedance tomography system (EIT), which can use the applied current and measurement voltage through the body surface electrode group, and use the reconstruction algorithm to construct an image imaging system that exceeds the cross-sectional, which can provide images of the internal physiological changes of the chest contour, in order to quantify the changes in lung function caused by rib fractures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 8, 2021
CompletedFirst Submitted
Initial submission to the registry
June 23, 2021
CompletedFirst Posted
Study publicly available on registry
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedSeptember 27, 2021
June 1, 2021
1.1 years
June 23, 2021
September 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
1st EIT test
Pulmonary function test with EIT before surgical in 72 hrs
In 72 hours
2nd EIT test
Pulmonary function test with EIT after surgical / (no surgical ) in 2nd weeks
In 2nd weeks
3rd EIT test
Pulmonary function test with EIT after surgical / (no surgical ) in 12th weeks
In 12th weeks
Study Arms (2)
Control
EXPERIMENTALparticipants receive no surgical treatment
Rib Fixation Surgery
EXPERIMENTALparticipants receive surgical treatment
Interventions
Which can use the applied current and measurement voltage through the body surface electrode group, and use the reconstruction algorithm to construct an image imaging system that exceeds the cross-sectional, which can provide images of the internal physiological changes of the chest contour, in order to quantify the changes in lung function caused by rib fractures.
Eligibility Criteria
You may qualify if:
- Over 20 years old
- At least 3 rib fractures due to thoracic trauma, or in compliance with the definition of flail chest.
- Consciousness Coma Index (GSC) 14 points or above
You may not qualify if:
- Consciousness coma index (GSC) less than 14 points
- BMI\> 50
- Have received thoracic surgery (including patients with partial and full lobes)
- Patients with pacemakers
- Spinal lesions or fractures of spinal instability
- Vulnerable population
- Patients who need to remove more than one lung lobe during surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Taiwan University Hospitallead
- Far Eastern Memorial Hospitalcollaborator
Study Sites (1)
National Taiwan University Hospital
Taipei, 10048, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hsien-Chi Liao, MD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2021
First Posted
June 30, 2021
Study Start
June 8, 2021
Primary Completion
July 31, 2022
Study Completion
December 31, 2022
Last Updated
September 27, 2021
Record last verified: 2021-06