Arterial Line in Trauma Resuscitation (ALTR)

• ClinicalTrials.gov Identifier: NCT05996068
• Recruitment Status: Recruiting
• First Posted: August 16, 2023
• Last Update Posted: August 16, 2023
• Sponsor: National Taiwan University Hospital
• Information provided by (Responsible Party): National Taiwan University Hospital

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
Major Trauma	Device: arterial line	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Enhancing Trauma Resuscitation Through Arterial Line Integration: A Before-After Study
• Actual Study Start Date: January 1, 2023
• Estimated Primary Completion Date: December 31, 2023
• Estimated Study Completion Date: December 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 ) [ 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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts

Contact: An-fu Lee; +886-5532-3911 ext 563329; m040608@hotmail.com.tw

Contact: Ming-tai Cheng; +886-5532-3911 ext 563329; jengmt1976@gmail.com

Locations

Taiwan

National Taiwan University Hospital Yunlin Branch; Recruiting

Douliu, Taiwan

Contact: An-fu Lee m040608@hotmail.com.tw

Sponsors and Collaborators

National Taiwan University Hospital

More Information

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.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05996068
• Other Study ID Numbers: 202210095DINC
• First Posted: August 16, 2023
• Last Update Posted: August 16, 2023
• Last Verified: December 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:

major trauma; arterial line; resuscitation

Additional relevant MeSH terms:

Wounds and Injuries