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Clinical Trials/NCT04946331
NCT04946331UnknownNot Applicable

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

National Taiwan University Hospital1 site in 1 country60 target enrollmentStarted: June 8, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
2nd EIT test

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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

Arms & Interventions

Control

Experimental

participants receive no surgical treatment

Intervention: Electrical impedance tomography system (Device)

Rib Fixation Surgery

Experimental

participants receive surgical treatment

Intervention: Electrical impedance tomography system (Device)

Outcomes

Primary Outcomes

2nd EIT test

Time Frame: In 2nd weeks

Pulmonary function test with EIT after surgical / (no surgical ) in 2nd weeks

1st EIT test

Time Frame: In 72 hours

Pulmonary function test with EIT before surgical in 72 hrs

3rd EIT test

Time Frame: In 12th weeks

Pulmonary function test with EIT after surgical / (no surgical ) in 12th weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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