Status Approved
First Submitted Date
2020/01/03
Registered Date
2020/01/29
Last Updated Date
2020/01/13
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004662 |
---|---|
Unique Protocol ID | CR319118 |
Public/Brief Title | The use of the "no zone" approach for assessment of traumatic neck injury |
Scientific Title | The use of the "no zone" approach for assessment of traumatic neck injury |
Acronym | UNATNI |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
---|---|
Board Approval Number | CR319118 |
Approval Date | 2019-10-22 |
Institutional Review Board Name | Yonsei University Wonju Severance Christian Hospital Institutional Review Board |
Institutional Review Board Address | 20, Ilsan-ro, Wonju-si, Gangwon-do |
Institutional Review Board Telephone | 033-741-1703 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | Pil Young Jung |
Title | M.D., Ph.D. |
Telephone | +82-33-741-0114 |
Affiliation | Yonsei University, Wonju Severance Christian Hospital |
Address | 20, Ilsan-ro, Wonju-si, Gangwon-do, Republic of Korea |
Contact Person for Public Queries | |
Name | Ji Wool Ko |
Title | M.D. |
Telephone | +82-33-741-0114 |
Affiliation | Yonsei University, Wonju Severance Christian Hospital |
Address | 20, Ilsan-ro, Wonju-si, Gangwon-do, Republic of Korea |
Contact Person for Updating Information | |
Name | Ji Wool Ko |
Title | M.D. |
Telephone | +82-33-741-0114 |
Affiliation | Yonsei University, Wonju Severance Christian Hospital |
Address | 20, Ilsan-ro, Wonju-si, Gangwon-do, Republic of Korea |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2019-10-31 Actual | |
Target Number of Participant | 168 | |
Primary Completion Date | 2020-01-10 , Anticipated | |
Study Completion Date | 2020-01-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Yonsei University, Wonju Severance Christian Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2019-10-31 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Yonsei University, Wonju Severance Christian Hospital |
Organization Type | Medical Institute |
Project ID | CR319118 |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Yonsei University, Wonju Severance Christian Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Traumatic neck injury comprises approximately 5-10% of all traumatic injuries. Despite its low incidence, the number of mortalities due to neck injury is still high. Anatomical features such as the trachea, esophagus, great vessels, and nerves are crowded in small spaces and are relatively unprotected. Therefore, mandatory surgery is generally performed in cases of zone II injury, according to the classification of the anatomical zones of the neck; zone I spans from the clavicles to the cricoid, zone II spans from cricoid to the angle of the mandible, and zone III ranges from the angle of the mandible to the base of the skull. This approach is referred to as the zone-based algorithm and is a traditional assessment for traumatic neck injury. Routine neck exploration in hemodynamically stable patients leads to a high rate of negative exploration, longer hospital stay, and an increased rate of complications, such as surgical site infection and sepsis. Therefore the management of neck injuries has changed from mandatory exploration of all wounds that penetrate the platysma to an increasingly selective approach, based on patient symptoms. The selective surgery is based on a “no zone” approach, which is to determine the direction of treatment by classifying the symptoms that can be caused by damage to the major vascular, digestive, and respiratory systems. If the patients are hemodynamically unstable or the hard signs are confirmed, surgery is performed without examination. Otherwise, the procedures are performed. The purpose of this study was to confirm the usefulness of the “no zone” approach in traumatic neck injuries. We hypothesized that hard signs in symptomatic approaches may be useful for predicting internal organ injuries in the neck. |
---|
8. Study Design
Study Type | Observational Study |
---|---|
Observational Study Model | Case-control |
Time Perspective | Retrospective |
Target Number of Participant | 168 |
Cohort/Group Number | 2 |
Cohort/ Group 1 |
Cohort/Group Label traumatic neck injury patients |
Cohort/Group Description Identify predictors of internal organ injury of neck by comparing groups with and without internal organ injury |
|
Cohort/ Group 2 |
Cohort/Group Label traumatic neck injury patients who underwent surgery |
Cohort/Group Description Identify predictors of internal organ injury of neck by comparing groups with and without internal organ injury in patients who underwent surgery |
|
Biospecimen Collection & Archiving |
: DNA Collect & Archive: Sample without DNA |
Biospecimen Description | hemoglobin, lactate, prothrombin time international normal ratio(PT-INR) |
9. Subject Eligibility
Study Population Description | Between January 2014 and December 2018, we prospectively enrolled patients with neck injuries who were treated at the Level I Trauma Center of Wonju Severance Christian Hospital and whose data were part of the Korea Trauma Data Bank (KTDB). |
---|---|
Sampling Method | Extraction of patients with diagnosis of traumatic neck injury in KTDB(Korean trauma data base) The purposive sampling was used as the non-probability extraction (non-probability extraction). |
Condition(s)/Problem(s) |
* (S00-T98)Injury, poisoning and certain other consequences of external causes (S19.9)Unspecified injury of neck neck injuries |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~No Limit |
|
Description Between January 2014 and December 2018, we prospectively enrolled patients with neck injuries who were treated at the Level I Trauma Center of Wonju Severance Christian Hospital and whose data were part of the Korea Trauma Data Bank (KTDB). |
|
Exclusion Criteria |
patients with only contusion of neck or whiplash syndrome were excluded |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | internal organs injuries (airway, vessels, nerve, digestive, thyroid and hyoid bone) of neck according to clinical signs (hard signs, soft signs, asymptomatic) |
|
Timepoint | Confirmation of clinical features(hard signs, soft signs, asymptomatic) upon arrival at the emergency room, and injuries to major organs in the neck (airway, vessels, nerve, digestive, thyroid and hyoid bone) after CT or surgery |
|
Secondary Outcome(s) 1 | ||
Outcome | Internal organs injuries (airway, vessels, nerve, digestive, thyroid and hyoid bone) of neck according to anatomical neck zone (zone I, II, III) |
|
Timepoint | Confirmation of anatomical zone (zone I, II, III) upon arrival at the emergency room, and injuries to major organs in the neck (airway, vessels, nerve, digestive, thyroid and hyoid bone) after CT or surgery |
11. Study Results and Publication
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
---|---|
Time of Sharing | 2020. 2 |
Way of Sharing | Available on Request
(jiulko@yonsei.ac.kr) |
TOP
BOTTOM
화면 최하단으로 이동