Arterial Line in Trauma Resuscitation

Study Overview
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Brief Summary
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Accident-related deaths is the 7th leading cause of death in Taiwan, and most of them is due to trauma from falls and traffic accident. Among trauma patients, the common cause of death is from hemorrhagic shock. Thus, real-time and accurate blood pressure monitoring is important for trauma patients. Incorrect blood pressure monitoring can lead to adverse events like traumatic cardiac arrest and shock and can also delay the time for intervention (fluid resuscitation, blood transfusion and operation). The current practice of blood pressure monitoring in trauma patient is by non-invasive blood pressure monitoring, which may be incorrect and not timely. Patient's body type and peripheral perfusion can both influence the result of non-invasive blood pressure monitoring. With continuous and correct blood pressure monitoring, the resuscitation team can give adequate and timely treatment. In some trauma centers, arterial line insertion in trauma patients is a daily practice, while the evidence is inadequate and the potential benefit in unknown. The main purpose of this study is to investigate the application of arterial line insertion in trauma patients. The study design is a prospective before-after study to exam whether arterial line insertion in trauma patients can reduce adverse event rate like hypovolemic shock and improve patient's outcomes.

Official Title
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Enhancing Trauma Resuscitation Through Arterial Line Integration: A Before-After Study

Conditions
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Major Trauma

Intervention / Treatment
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* Device: arterial line


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Glasgow Coma Scale (GCS) 13 or less SBP < 90 mmHg Respiratory rate < 10 or > 29 breaths/min Fall from height > 6 meters High-Risk Auto Crash: Partial or complete ejection, intrusion > 30 cm any site, Need for extrication for entrapped patient, Death in passenger compartment Rider separated from transport vehicle with significant impact Penetrating injuries to head, neck, torso, and proximal extremities Skull deformity, suspected skull fracture Chest wall instability, deformity, or suspected flail chest Suspected pelvic fracture Suspected fracture of two or more proximal long bones Amputation proximal to wrist or ankle Active bleeding requiring a tourniquet or wound packing with continuous pressure Burns in conjunction with trauma Exclusion Criteria: Pregnancy Patient or family who are unable to obtain informed consent Known coagulopathy that is inappropriate for arterial line insertion Known peripheral arterial occlusion disease that is inappropriate for arterial line insertion traumatic cardiac arrest

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: We use se before-after study type and only the after phase receive intervention. Before phase will retrospectively collect data from patient without arterial line intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: trauma patients with arterial line insertion<br>the after phase, actively recruited patients who are eligible for arterial line insertion | Device: arterial line<br>* insert arterial line for patients who meet major trauma criteria<br>|
| No Intervention: trauma patients without arterial line insertion<br>the before phase, retrospectively data collection from the past | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index ) | including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index (HR/SBP)>1 | during ER stay, up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prolong ICU admission | define as > 6 days of admission | up to 7 days | 
| 30 days mortality rate | mortality within 30 days of trauma event | mortality within 30 days of trauma event | 
| volume of fluid administration | any type of fluid administration | during ER stay, up to 6 hours | 
| units of red blood cell transfusion | units of red blood cell transfusion | during ER stay, up to 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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major trauma, arterial line, resuscitation