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Arterial Line in Trauma Resuscitation (ALTR)

Primary Purpose

Major Trauma

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
arterial line
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Major Trauma focused on measuring major trauma, arterial line, resuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital Yunlin BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

trauma patients with arterial line insertion

trauma patients without arterial line insertion

Arm Description

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

the before phase, retrospectively data collection from the past

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

prolong ICU admission
define as > 6 days of admission
30 days mortality rate
mortality within 30 days of trauma event
volume of fluid administration
any type of fluid administration
units of red blood cell transfusion
units of red blood cell transfusion

Full Information

First Posted
August 3, 2023
Last Updated
August 10, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05996068
Brief Title
Arterial Line in Trauma Resuscitation
Acronym
ALTR
Official Title
Enhancing Trauma Resuscitation Through Arterial Line Integration: A Before-After Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Trauma
Keywords
major trauma, arterial line, resuscitation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
trauma patients with arterial line insertion
Arm Type
Active Comparator
Arm Description
the after phase, actively recruited patients who are eligible for arterial line insertion
Arm Title
trauma patients without arterial line insertion
Arm Type
No Intervention
Arm Description
the before phase, retrospectively data collection from the past
Intervention Type
Device
Intervention Name(s)
arterial line
Intervention Description
insert arterial line for patients who meet major trauma criteria
Primary Outcome Measure Information:
Title
composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index )
Description
including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index (HR/SBP)>1
Time Frame
during ER stay, up to 6 hours
Secondary Outcome Measure Information:
Title
prolong ICU admission
Description
define as > 6 days of admission
Time Frame
up to 7 days
Title
30 days mortality rate
Description
mortality within 30 days of trauma event
Time Frame
mortality within 30 days of trauma event
Title
volume of fluid administration
Description
any type of fluid administration
Time Frame
during ER stay, up to 6 hours
Title
units of red blood cell transfusion
Description
units of red blood cell transfusion
Time Frame
during ER stay, up to 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
An-fu Lee
Phone
+886-5532-3911
Ext
563329
Email
m040608@hotmail.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-tai Cheng
Phone
+886-5532-3911
Ext
563329
Email
jengmt1976@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital Yunlin Branch
City
Douliu
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
An-fu Lee
Email
m040608@hotmail.com.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
18212658
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.
Results Reference
background
PubMed Identifier
2927596
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.
Results Reference
background
PubMed Identifier
2213158
Citation
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.
Results Reference
background
PubMed Identifier
17426904
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.
Results Reference
background
PubMed Identifier
25807399
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.
Results Reference
background
PubMed Identifier
35887844
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.
Results Reference
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Arterial Line in Trauma Resuscitation

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