NCT05549986

Brief Summary

We evaluated a cohort of adult trauma patients transported to emergency departments. The first vital signs were used to calculate the SI, MSI, and rSIG. The areas under the receiver operating characteristic curves (AUROCs) and test results were used to compare the discriminant performance of the indices on short-term mortality and poor functional outcome. A subgroup analysis of geriatric patients, traumatic brain injury, penetrating injury, and non-penetrating injury was performed.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105,641

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

5 years

First QC Date

August 29, 2022

Last Update Submit

September 18, 2022

Conditions

Keywords

Shock index(SI)Modified Shock Index (MSI)Reverse Shock Index Multiplied by the Glasgow Coma Scale (rSIG)MortalityPan-Asian Trauma Outcomes Study (PATOS)

Outcome Measures

Primary Outcomes (1)

  • Discriminant power of SI, MSI, and rSIG on short-term mortality for adult traumatic patients

    AUROC in associated with short-term mortality with SI, MSI, rSIG

    30 days

Secondary Outcomes (1)

  • Discriminant power of SI, MSI, and rSIG on functional outcome for adult traumatic patients

    We defined no symptoms, no significant disability, slight disability, and moderate disability (MRS 0-3) as favorable functional outcomes and moderately severe disability, severe disability, and death (MRS 4-6) as poor functional outcomes

Study Arms (2)

Mortality group

Patients encountered in-hospital mortality or 30-day mortality

Other: Observational

Survival group

Patients did not encounter in-hospital mortality or 30-day mortality

Other: Observational

Interventions

Observational

Mortality groupSurvival group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study included adult patients (≥18 years) EMS-transported from January 2016 to December 2020. Patients with missing entries of age, sex, triage, SBP, DBP, HR, or GCS were excluded. Entries with missing records of in-hospital mortality or 30-day mortality were excluded from the short-term mortality cohort analyses. Patients without a Modified Rankin Scale (MRS) record at discharge were excluded from the functional outcome cohort analyses.

You may qualify if:

  • Adult patients (≥18 years) EMS-transported from January 2016 to December 2020

You may not qualify if:

  • Patients with missing entries of age, sex, triage, SBP, DBP, HR, or GCS were excluded.
  • Entries with missing records of in-hospital mortality or 30-day mortality were excluded from the short-term mortality cohort analyses.
  • Patients without a Modified Rankin Scale (MRS) record at discharge were excluded from the functional outcome cohort analyses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chen TH, Wu MY, Do Shin S, Jamaluddin SF, Son DN, Hong KJ, Jen-Tang S, Tanaka H, Hsiao CH, Hsieh SL, Chien DK, Tsai W, Chang WH, Chiang WC; PATOS Clinical Research Network. Discriminant ability of the shock index, modified shock index, and reverse shock index multiplied by the Glasgow coma scale on mortality in adult trauma patients: a PATOS retrospective cohort study. Int J Surg. 2023 May 1;109(5):1231-1238. doi: 10.1097/JS9.0000000000000287.

MeSH Terms

Conditions

Wounds and InjuriesShock, Traumatic

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Tse-Hao Chen, M.D.

    Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2022

First Posted

September 22, 2022

Study Start

January 1, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share