Arterial Line in Trauma Resuscitation (ALTR)

National Taiwan University

Status: Active, not recruiting

Conditions: Major Trauma

Treatments: Device: arterial line

Study type: Interventional

Funder types: Other

Identifiers

NCT05996068

202210095DINC

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

trauma patients with arterial line insertion

Active Comparator group

Description:

the after phase, actively recruited patients who are eligible for arterial line insertion

Treatment:

Device: arterial line

trauma patients without arterial line insertion

No Intervention group

Description:

the before phase, retrospectively data collection from the past