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NCT Number: NCT05996068

Arterial Line in Trauma Resuscitation

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.

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Key information

Conditions

Major Trauma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital Yunlin Branch

Douliu, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arterial line

Device

insert arterial line for patients who meet major trauma criteria

Primary outcomes

  1. composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index )

    Time frame: during ER stay, up to 6 hours

    including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index (HR/SBP)>1

Secondary outcomes

  1. prolong ICU admission

    Time frame: up to 7 days

    define as > 6 days of admission

  2. 30 days mortality rate

    Time frame: mortality within 30 days of trauma event

    mortality within 30 days of trauma event

  3. volume of fluid administration

    Time frame: during ER stay, up to 6 hours

    any type of fluid administration

  4. Area under curve (AUC) difference under different time measuring frequency

    Time frame: 1/3/5/10 minutes

    We 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).

  5. units of red blood cell transfusion

    Time frame: during ER stay, up to 6 hours

    units of red blood cell transfusion

  6. arterial blood pressure trajectory

    Time frame: during ER stay, up to 6 hours

    We will depict the arterial blood pressure trajectory for each patient.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Acronym: ALTR

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 16, 2023
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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