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 Study

September 18, 2022 updated by: Tse-Hao Chen, Mackay Memorial Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

105641

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mortality group
Patients encountered in-hospital mortality or 30-day mortality
Other: Observational
Observational
Survival group
Patients did not encounter in-hospital mortality or 30-day mortality
Other: Observational
Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discriminant power of SI, MSI, and rSIG on short-term mortality for adult traumatic patients
Time Frame: 30 days
AUROC in associated with short-term mortality with SI, MSI, rSIG
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discriminant power of SI, MSI, and rSIG on functional outcome for adult traumatic patients
Time Frame: 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
AUROC in associated with functional outcome with SI, MSI, rSIG
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Investigators

  • Principal Investigator: Tse-Hao Chen, M.D., Mackay Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

September 18, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 18, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21MMHIS389e

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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