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Rib FracturesEITNCT04946331

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

A study testing Electrical impedance tomography system in people with Rib Fractures, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Rib Fractures
What is being tested?
Electrical impedance tomography system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
8 Jun 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, 10048

    Hsien-Chi Liao, 886-2-23123456 ext. 51611, polarisliao@hotmail.com

    Recruiting

Other trials in Taiwan

About this study

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.

Read the 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.

Conditions
Rib Fractures
Being tested
Electrical impedance tomography system
Keywords
Pulmonary function, Electrical impedance tomography system
Medical subject headings
Rib Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrical impedance tomography systemDevice

    Also called 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 groups in NCT04946331
Study groupRoleWhat they receive
ControlExperimentalparticipants receive no surgical treatment
Receives: Device: Electrical impedance tomography system
Rib Fixation SurgeryExperimentalparticipants receive surgical treatment
Receives: Device: Electrical impedance tomography system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1st EIT test

    Pulmonary function test with EIT before surgical in 72 hrs

    Measured: In 72 hours

  2. 2nd EIT test

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

    Measured: In 2nd weeks

  3. 3rd EIT test

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

    Measured: In 12th weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start8 Jun 2021
  3. Primary completion31 Jul 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04946331
Sponsor's protocol ID
202103085RIPC
Acronym
EIT
Status last verified
Jun 2021
First submitted
23 Jun 2021
Last updated
27 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Electrical impedance tomography system in people with Rib Fractures, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hsien-Chi Liao, MD (+886-23123456 ext. 51611, polarisliao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1st EIT test (time frame: In 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.

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EIT Clinical Trial NCT04946331 | AzTrials