Commonly Used Drug Regimens for Rapid Sequence Intubation (RSI) of Trauma Patients in the Emergency Department

Airway is the first step in the initial assessment of a trauma patient. Often this assessment determines the need for endotracheal intubation, most commonly by rapid sequence intubation (RSI). Currently, there is no consensus on best practice for RSI drug regimens. Given the fragmented nature of this topic, most RSI drugs are chosen by the intubating physician based on their experience (i.e., a "dealer's choice"). Overall, emergency medical care is moving towards standardization to decrease medical errors and improve outcomes. Clearly, the current approach to RSI drug regimens does not align with those goals.

This study seeks first to define commonly used RSI drug regimens for trauma, and second to investigate hospital course and long-term health outcomes as a potential way to define best practice RSI drugs for trauma patients.

The study will be a multi-center retrospective chart review of data collected from January 1, 2014 to January 1, 2019, and will include Level I trauma centers in Texas. The University of Texas at Austin (UTA) is hosting this study as a Texas Level I Trauma Centers Multicenter Trial. Additional sites will have their own institutional IRB approval and will provide de-identified data to the principal investigator (PI) via secure encrypted email. Data will be submitted for MDMC trauma patients to UTA and analyzed within the Dell Med Department of Surgery and Perioperative Care and treated in the same way with the same security as data collected at Dell Seton Medical Center. The plan to complete the data collection and analysis by January 1, 2021.

After de-identification, descriptive statistical analysis will be performed. Statistics reported will include frequencies. Logistic regression model to predict outcome will be performed. Odds ratio, confidence interval, and P value will be reported using logistic regression for outcome models for both adjusted and unadjusted models. The statistical software package SAS 9.3 will be used for all calculations.

Study Overview

• Status: Withdrawn
• Conditions: Trauma Patients

Detailed Description

Airway is the first step in the initial assessment of a trauma patient. Often this assessment determines the need for endotracheal intubation, most commonly by rapid sequence intubation (RSI). Currently, there is no consensus on best practice for RSI drug regimens. The research on drugs for RSI mainly focused on immediate hemodynamic effect, number of intubation attempts, and, more recently, adrenal insufficiency related to etomidate administration. There is little research, and no American multicenter research, on non-immediate health outcomes such as mortality. Additionally, there is a growing body of literature that suggests trauma patients may respond differently to RSI regimens than other critically ill patients. Given the fragmented nature of this topic, most RSI drugs are chosen by the intubating physician based on their experience (i.e., a "dealer's choice"). Overall, emergency medical care is moving towards standardization to decrease medical errors and improve outcomes. Clearly, the current approach to RSI drug regimens does not align with those goals.

There are three major gaps in the literature. First, there is no definition of the commonly used RSI drug regimens for trauma patients. It is essential to define common RSI drug regimens in order to facilitate future research and analyze drug efficacy. Second, the unique response of trauma patients to RSI drugs has not been elucidated. Third, there is little description of short and long term (vs. solely short term) outcomes for each of the RSI regimens. This will be an essential piece of information when discussing standardization and deciding which regimens are best suited for patients.

This study seeks first to define commonly used RSI drug regimens for trauma, and second to investigate hospital course and long-term health outcomes as a potential way to define best practice RSI drugs for trauma patients.

The study will be a multi-center retrospective chart review of data collected from January 1, 2014 to January 1, 2019, and will include Level I trauma centers in Texas. The University of Texas at Austin (UTA) is hosting this study as a Texas Level I Trauma Centers Multicenter Trial. Additional sites will have their own institutional IRB approval and will provide de-identified data to the principal investigator (PI) via secure encrypted email. Data will be submitted for MDMC trauma patients to UTA and analyzed within the Dell Med Department of Surgery and Perioperative Care and treated in the same way with the same security as data collected at Dell Seton Medical Center. After data abstraction, the PI will de-identify data before analysis, removing name, and medical record number (MRN). All data recording and collection will include a computer, which is secured via password. Documents will be password protected, hosted on UT Box, and only downloaded after de-identification. Only the PI, Co-PI, and research coordinators will have access to the data. The dataset will be password protected. No identifiable health information will be used in reporting of data, whether that is in publication or presentation format. The investigators plan to complete the data collection and analysis by January 1, 2021.

After de-identification, descriptive statistical analysis will be performed. Statistics reported will include frequencies. Logistic regression model to predict outcome will be performed. Odds ratio, confidence interval, and P value will be reported using logistic regression for outcome models for both adjusted and unadjusted models. The statistical software package SAS 9.3 will be used for all calculations.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult trauma patients with intubation attempt in emergency department

Description

Inclusion Criteria:

• Any adult (18 to 89 years old)
• Traumatic injury
• Intubation attempt made in the emergency department

Exclusion Criteria:

• Prisoners
• Pregnant Women
• Patients less than 18 years of age

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Age (in years)	January 1, 2014 to January 1, 2019
Prehospital vitals	Vital signs collected prior to hospitalization	January 1, 2014 to January 1, 2019
Emergency department vitals	Vitals recorded in the emergency department	January 1, 2014 to January 1, 2019
Peri-intubation vitals	Vitals recorded prior to intubation	January 1, 2014 to January 1, 2019
AIS	(Abbreviated Injury Score)	January 1, 2014 to January 1, 2019
Death Rate	rate of death	January 1, 2014 to January 1, 2019
ISS	(Injury Severity Score)	January 1, 2014 to January 1, 2019
Hospital Length of Stay	The number of days subject was admitted.	January 1, 2014 to January 1, 2019
ICU Length of Stay	The number of days the subject was admitted into the ICU.	January 1, 2014 to January 1, 2019
Ventilation days	The number of days the subject ventilated.	January 1, 2014 to January 1, 2019
Return to Hospital in <30d		January 1, 2014 to January 1, 2019
Discharge Disposition	discharge status	January 1, 2014 to January 1, 2019
Demographics-Sex	Male or female	January 1, 2014 to January 1, 2019
Demographics-Race	Race of subject	January 1, 2014 to January 1, 2019
Demographics-Trauma Type	Type of trauma	January 1, 2014 to January 1, 2019
Commonly Used Drug Regimens for Rapid Sequence Intubation (RSI) of Trauma Patients in the Emergency Department	Commonly Used Drug Regimens for Rapid Sequence Intubation (RSI) of Trauma Patients in the Emergency Department	January 1, 2014 to January 1, 2019

Collaborators and Investigators

• Sponsor: Methodist Health System
• Collaborators: University of Texas at Austin
• Investigators: Principal Investigator: Michael S Truitt, MD, Methodist Health System

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Wounds and Injuries
• Other Study ID Numbers: 069.GME.2019.D

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