Is There a Worse Outcome When the Systolic Blood Pressure is Lower Than Heart Rate in Those Adult Trauma Patients With Isolated Head/Neck Injury

A systolic blood pressure (SBP) lower than the heart rate (HR) could indicate a poor condition in trauma patients. In such scenarios, the reversed shock index (RSI) is <1, as calculated by the SBP divided by the HR. This study aimed to clarify whether RSI could be used to identify high-risk adult patients with isolated traumatic brain injury (TBI).

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: reversed shock index < 1; Other: reversed shock index ≥ 1

• Study Type: Observational
• Enrollment (Actual): 1216

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients having isolated TBI with a head abbreviated injury scale (AIS) ≥ 3 and without severe injury to other regions (other AIS ≤ 1) were included. We excluded patients younger than 18 or older than 65 years of age. Patients were grouped and analyzed according to RSI (< 1 or ≥ 1).

Description

Inclusion Criteria:

• Adult patients having isolated TBI with a head abbreviated injury scale (AIS) ≥ 3 and without severe injury to other regions (other AIS ≤ 1) were included

Exclusion Criteria:

• Patients with incomplete registered data were also excluded

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
isolated traumatic brain injury; Adult patients having isolated traumatic brain injury with a head abbreviated injury scale (AIS) ≥ 3 and without severe injury to other regions (other AIS ≤ 1) were included. The patients were grouped and analyzed according to reversed shock index < 1 or reversed shock index ≥ 1.	Other: reversed shock index < 1; Among patients with isolated TBI, those with an RSI < 1 had higher mortality; Other: reversed shock index ≥ 1; Among patients with isolated TBI, those with an RSI ≥ 1 had lower mortality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
in-hospital mortality	To measure the outcome of patients.	up to 5 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2016
• Primary Completion (ACTUAL): January 23, 2017
• Study Completion (ACTUAL): February 22, 2017

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (ACTUAL): October 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: mortality; traumatic brain injury; systolic blood pressure; reversed shock index
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Heart Murmurs; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Systolic Murmurs; Neck Injuries
• Other Study ID Numbers: CGRPG8F0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make individual participant data available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No