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Arterial Line in Trauma Resuscitation

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05996068
Acronym
ALTR
Enrollment
216
Registered
2023-08-16
Start date
2023-01-01
Completion date
2025-06-30
Last updated
2024-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Trauma

Keywords

major trauma, arterial line, resuscitation

Brief summary

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.

Interventions

DEVICEarterial line

insert arterial line for patients who meet major trauma criteria

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index )during ER stay, up to 6 hoursincluding any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index (HR/SBP)\>1

Secondary

MeasureTime frameDescription
30 days mortality ratemortality within 30 days of trauma eventmortality within 30 days of trauma event
volume of fluid administrationduring ER stay, up to 6 hoursany type of fluid administration
prolong ICU admissionup to 7 daysdefine as \> 6 days of admission
units of red blood cell transfusionduring ER stay, up to 6 hoursunits of red blood cell transfusion
arterial blood pressure trajectoryduring ER stay, up to 6 hoursWe will depict the arterial blood pressure trajectory for each patient.
Area under curve (AUC) difference under different time measuring frequency1/3/5/10 minutesWe will use continuous blood pressure data and apply different intervals (1, 3, 5, and 10 minutes) to create a plot, then smooth it to calculate the area under the curve (AUC).

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026