ALTR: Arterial Line in Trauma Resuscitation

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05996068
Collaborator
(none)
216
1
2
12
18.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: arterial line
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
216 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
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.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)
Primary Purpose:
Diagnostic
Official Title:
Enhancing Trauma Resuscitation Through Arterial Line Integration: A Before-After Study
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: trauma patients with arterial line insertion

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

Device: arterial line
insert arterial line for patients who meet major trauma criteria

No Intervention: trauma patients without arterial line insertion

the before phase, retrospectively data collection from the past

Outcome Measures

Primary Outcome Measures

  1. composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index ) [during ER stay, up to 6 hours]

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

Secondary Outcome Measures

  1. prolong ICU admission [up to 7 days]

    define as > 6 days of admission

  2. 30 days mortality rate [mortality within 30 days of trauma event]

    mortality within 30 days of trauma event

  3. volume of fluid administration [during ER stay, up to 6 hours]

    any type of fluid administration

  4. units of red blood cell transfusion [during ER stay, up to 6 hours]

    units of red blood cell transfusion

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Yunlin Branch Douliu Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05996068
Other Study ID Numbers:
  • 202210095DINC
First Posted:
Aug 16, 2023
Last Update Posted:
Aug 16, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2023