Comparison of Lung Function Based on Electrical Impedance Tomography and CT Lung Volume in Patients With Rib Fractures (EIT)
Primary Purpose
Rib Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Electrical impedance tomography system
Sponsored by
About this trial
This is an interventional other trial for Rib Fractures focused on measuring Pulmonary function, Electrical impedance tomography system
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control
Rib Fixation Surgery
Arm Description
participants receive no surgical treatment
participants receive surgical treatment
Outcomes
Primary Outcome Measures
1st EIT test
Pulmonary function test with EIT before surgical in 72 hrs
2nd EIT test
Pulmonary function test with EIT after surgical / (no surgical ) in 2nd weeks
3rd EIT test
Pulmonary function test with EIT after surgical / (no surgical ) in 12th weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT04946331
First Posted
June 23, 2021
Last Updated
September 24, 2021
Sponsor
National Taiwan University Hospital
Collaborators
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04946331
Brief Title
Comparison of Lung Function Based on Electrical Impedance Tomography and CT Lung Volume in Patients With Rib Fractures
Acronym
EIT
Official Title
Comparison of Lung Function Based on Electrical Impedance Tomography and CT Lung Volume in Patients With Rib Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Far Eastern Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Rib fractures are one of the most common injuries following blunt trauma, occurring in approximately 10% of all trauma patients. Rib fracture injuries extend across a broad spectrum of severity from a single fractured rib which may be sustained in a fall or sporting injury, to multiple fractured ribs resulting in a flail chest with paradoxical chest wall movement and respiratory failure.
Flail chest, which defines multiple adjacent ribs broken in multiple places, is the most serious chest injury, and it damages the chest wall integrity and causes "paradoxical motion" from the detachment of a segment from the rest of the chest wall. Surgical management of rib fractures has received increasing attention in recent years with the development of new fixation techniques.
The mortality rate is 4% to 20%. Flail chest (FC), which defines multiple adjacent ribs broken in multiple places, is the most serious chest injury, and it damages the chest wall integrity and causes "paradoxical motion" from the detachment of a segment from the rest of the chest wall. Pulmonary contusion (PC) is the most common chest injury. These conditions frequently exist at the same time. Currently, a deeper understanding of FC pathophysiology exists, and its management has evolved substantially over the past 6 decades.
The earliest treatment for FC was surgery. With the increasing technological advancements available in the intensive care unit, conservative management, based on mechanical ventilation supplemented with intensive pain control, has become more common. Using positive airway pressure to reduce the asynchronous movement of FC could avoid surgical risks and postoperative complications. Conservative treatment has been administered frequently in previous years.
A growing number of researchers have found that surgery for FC could reduce the duration of mechanical ventilation, the ICU length of stay, the hospital length of stay, the incidence of pneumonia and tracheostomy, and mortality. Additional benefits included decreased doses of analgesic and sedative drugs and avoidance of thoracic deformity, and patients could return to previous employment quicker than could those treated conservatively.
Therefore, the improvement of lung function is a key indicator for the treatment of rib fractures and thoracic trauma, because lung function is related to lung expansion, chest wall stability, and thoracic deformation, which can lead to pneumonia, respiratory failure, difficult weaning, and prolong hospitalization. However, traditional pulmonary function measurement is based on an Incentive Spirometry. This examination requires the cooperation of the patient and also requires sufficient space and equipment. It is not suitable for acute trauma patients in intensive care units. In addition, the induced spirometer can only measure respiratory parameters such as vital capacity. It cannot locate and monitor the collapse part of lung and the range of pulmonary atelectasis. It must rely heavily on computer tomography and other imaging assistance, which is very unsatisfactory. Therefore, how to simultaneously develop an effective monitoring method for lung function and lung expansion is the current top priority.
For these reason, 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.
This study is a combine research project of patients from the Department of Traumatology of National Taiwan University Hospital and the Department of Traumatology of Far Eastern Memorial Hospital. The study is expected to be collected from July 2021 to December 2022 for one and a half years. Hospitalized patients with traumatic rib fractures were collected and analyzed in a prospective study method, and the patients with internal rib fractures in Far Eastern Memorial Hospital were collected and analyzed, and their lung function changes after the operation will be tracked.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures
Keywords
Pulmonary function, Electrical impedance tomography system
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
participants receive no surgical treatment
Arm Title
Rib Fixation Surgery
Arm Type
Experimental
Arm Description
participants receive surgical treatment
Intervention Type
Device
Intervention Name(s)
Electrical impedance tomography system
Other Intervention Name(s)
EIT
Intervention Description
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.
Primary Outcome Measure Information:
Title
1st EIT test
Description
Pulmonary function test with EIT before surgical in 72 hrs
Time Frame
In 72 hours
Title
2nd EIT test
Description
Pulmonary function test with EIT after surgical / (no surgical ) in 2nd weeks
Time Frame
In 2nd weeks
Title
3rd EIT test
Description
Pulmonary function test with EIT after surgical / (no surgical ) in 12th weeks
Time Frame
In 12th weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsien-Chi Liao, MD
Phone
+886-23123456
Ext
51611
Email
polarisliao@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsien-Chi Liao, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsien-Chi Liao
Phone
886-2-23123456
Ext
51611
Email
polarisliao@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of Lung Function Based on Electrical Impedance Tomography and CT Lung Volume in Patients With Rib Fractures
We'll reach out to this number within 24 hrs