Arterial Line in Trauma Resuscitation

NCT05996068 | Active Not Recruiting

• 1 other identifier: 202210095DINC
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Trauma

Keywords

major trauma; arterial line; resuscitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• prolong ICU admission

  up to 7 days

• 30 days mortality rate

  mortality within 30 days of trauma event

• volume of fluid administration

  during ER stay, up to 6 hours

• Area under curve (AUC) difference under different time measuring frequency

  1/3/5/10 minutes

• units of red blood cell transfusion

  during ER stay, up to 6 hours

Study Arms (2)

trauma patients with arterial line insertion

ACTIVE COMPARATOR

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

Device: arterial line

trauma patients without arterial line insertion

NO INTERVENTION

the before phase, retrospectively data collection from the past

Interventions

arterial line DEVICE

insert arterial line for patients who meet major trauma criteria

trauma patients with arterial line insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Yunlin Branch

Douliu, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 18212658 BACKGROUND

• 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.

  PMID: 2927596 BACKGROUND

• 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.

  PMID: 2213158 BACKGROUND

• 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.

  PMID: 17426904 BACKGROUND

• 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.

  PMID: 25807399 BACKGROUND

• 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.

  PMID: 35887844 BACKGROUND

MeSH Terms

Interventions

Vascular Access Devices

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 16, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-08

Locations

TW (1)