Arterial Line in Trauma Resuscitation

Major Trauma Clinical Trial

— ALTR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996068
• Other study ID #: 202210095DINC
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: National Taiwan University Hospital
• Contact: An-fu Lee
• Phone: +886-5532-3911
• Email: m040608[@]hotmail.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Major Trauma
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Yunlin Branch	Douliu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	prolong ICU admission	define as > 6 days of admission	up to 7 days
Secondary	30 days mortality rate	mortality within 30 days of trauma event	mortality within 30 days of trauma event
Secondary	volume of fluid administration	any type of fluid administration	during ER stay, up to 6 hours
Secondary	units of red blood cell transfusion	units of red blood cell transfusion	during ER stay, up to 6 hours