Comparison of Lung Function Based on Electrical Impedance Tomography and CT Lung Volume in Patients With Rib Fractures (EIT)

September 24, 2021 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10048
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Over 20 years old
  2. At least 3 rib fractures due to thoracic trauma, or in compliance with the definition of flail chest.
  3. Consciousness Coma Index (GSC) 14 points or above

Exclusion Criteria:

  1. Consciousness coma index (GSC) less than 14 points
  2. BMI> 50
  3. Have received thoracic surgery (including patients with partial and full lobes)
  4. Patients with pacemakers
  5. Spinal lesions or fractures of spinal instability
  6. Vulnerable population
  7. Patients who need to remove more than one lung lobe during surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rib Fixation Surgery
participants receive surgical treatment
Device: Electrical impedance tomography system
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.
Other Names:
  • EIT
Experimental: Control
participants receive no surgical treatment
Device: Electrical impedance tomography system
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.
Other Names:
  • EIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1st EIT test
Time Frame: In 72 hours
Pulmonary function test with EIT before surgical in 72 hrs
In 72 hours
2nd EIT test
Time Frame: In 2nd weeks
Pulmonary function test with EIT after surgical / (no surgical ) in 2nd weeks
In 2nd weeks
3rd EIT test
Time Frame: In 12th weeks
Pulmonary function test with EIT after surgical / (no surgical ) in 12th weeks
In 12th weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Far Eastern Memorial Hospital

Investigators

  • Study Director: Hsien-Chi Liao, MD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 23, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202103085RIPC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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