Arterial Line in Trauma Resuscitation (ALTR)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Major Trauma
• Intervention / Treatment: Device: arterial line

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Douliu, Taiwan
    • National Taiwan University Hospital Yunlin Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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
Area under curve (AUC) difference under different time measuring frequency	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).	1/3/5/10 minutes
arterial blood pressure trajectory	We will depict the arterial blood pressure trajectory for each patient.	during ER stay, up to 6 hours

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• Teixeira PG, Inaba K, Hadjizacharia P, Brown C, Salim A, Rhee P, Browder T, Noguchi TT, Demetriades D. Preventable or potentially preventable mortality at a mature trauma center. J Trauma. 2007 Dec;63(6):1338-46; discussion 1346-7. doi: 10.1097/TA.0b013e31815078ae.
• Klauber MR, Marshall LF, Luerssen TG, Frankowski R, Tabaddor K, Eisenberg HM. Determinants of head injury mortality: importance of the low risk patient. Neurosurgery. 1989 Jan;24(1):31-6. doi: 10.1227/00006123-198901000-00005.
• Eisenberg HM, Gary HE Jr, Aldrich EF, Saydjari C, Turner B, Foulkes MA, Jane JA, Marmarou A, Marshall LF, Young HF. Initial CT findings in 753 patients with severe head injury. A report from the NIH Traumatic Coma Data Bank. J Neurosurg. 1990 Nov;73(5):688-98. doi: 10.3171/jns.1990.73.5.0688.
• Tieu BH, Holcomb JB, Schreiber MA. Coagulopathy: its pathophysiology and treatment in the injured patient. World J Surg. 2007 May;31(5):1055-64. doi: 10.1007/s00268-006-0653-9.
• Schreiber MA, Meier EN, Tisherman SA, Kerby JD, Newgard CD, Brasel K, Egan D, Witham W, Williams C, Daya M, Beeson J, McCully BH, Wheeler S, Kannas D, May S, McKnight B, Hoyt DB; ROC Investigators. A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial. J Trauma Acute Care Surg. 2015 Apr;78(4):687-95; discussion 695-7. doi: 10.1097/TA.0000000000000600.
• Wijnberge M, van der Ster B, Vlaar APJ, Hollmann MW, Geerts BF, Veelo DP. The Effect of Intermittent versus Continuous Non-Invasive Blood Pressure Monitoring on the Detection of Intraoperative Hypotension, a Sub-Study. J Clin Med. 2022 Jul 14;11(14):4083. doi: 10.3390/jcm11144083.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 10, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: major trauma; resuscitation; arterial line
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 202210095DINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No