Commonly Used Drug Regimens for Rapid Sequence Intubation (RSI) of Trauma Patients in the Emergency Department
- Conditions
- Trauma Patients
- Registration Number
- NCT05243420
- Lead Sponsor
- Methodist Health System
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Any adult (18 to 89 years old)
- Traumatic injury
- Intubation attempt made in the emergency department
- Prisoners
- Pregnant Women
- Patients less than 18 years of age
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Commonly Used Drug Regimens for Rapid Sequence Intubation (RSI) of Trauma Patients in the Emergency Department January 1, 2014 to January 1, 2019 Commonly Used Drug Regimens for Rapid Sequence Intubation (RSI) of Trauma Patients in the Emergency Department
Emergency department vitals January 1, 2014 to January 1, 2019 Vitals recorded in the emergency department
Hospital Length of Stay January 1, 2014 to January 1, 2019 The number of days subject was admitted.
Demographics January 1, 2014 to January 1, 2019 Age (in years)
Prehospital vitals January 1, 2014 to January 1, 2019 Vital signs collected prior to hospitalization
Peri-intubation vitals January 1, 2014 to January 1, 2019 Vitals recorded prior to intubation
AIS January 1, 2014 to January 1, 2019 (Abbreviated Injury Score)
ISS January 1, 2014 to January 1, 2019 (Injury Severity Score)
Ventilation days January 1, 2014 to January 1, 2019 The number of days the subject ventilated.
Return to Hospital in <30d January 1, 2014 to January 1, 2019 Demographics-Sex January 1, 2014 to January 1, 2019 Male or female
Death Rate January 1, 2014 to January 1, 2019 rate of death
ICU Length of Stay January 1, 2014 to January 1, 2019 The number of days the subject was admitted into the ICU.
Discharge Disposition January 1, 2014 to January 1, 2019 discharge status
Demographics-Race January 1, 2014 to January 1, 2019 Race of subject
Demographics-Trauma Type January 1, 2014 to January 1, 2019 Type of trauma
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States