Arterial Line in Trauma Resuscitation

NCT ID: NCT05996068

Last Updated: 2024-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Major Trauma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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trauma patients with arterial line insertion

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

Group Type ACTIVE_COMPARATOR

arterial line

Intervention Type DEVICE

insert arterial line for patients who meet major trauma criteria

trauma patients without arterial line insertion

the before phase, retrospectively data collection from the past

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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arterial line

insert arterial line for patients who meet major trauma criteria

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital Yunlin Branch

Douliu, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 18212658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2927596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2213158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17426904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25807399 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35887844 (View on PubMed)

Other Identifiers

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202210095DINC

Identifier Type: -

Identifier Source: org_study_id

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