Clinical trial NCT05243420: Commonly Used Drug Regimens for Rapid Sequence Intubation (RSI) of Trauma Patients in the Emergency Department
Official title: Commonly Used Drug Regimens for Rapid Sequence Intubation (RSI) of Trauma Patients in the Emergency Department
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Trauma Patients
Lead sponsor: Methodist Health System
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
First posted: 2022-02-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult trauma patients with intubation attempt in emergency department

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.

Eligibility criteria: 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

Primary outcomes:
measure: Commonly Used Drug Regimens for Rapid Sequence Intubation (RSI) of Trauma Patients in the Emergency Department
timeFrame: January 1, 2014 to January 1, 2019
measure: Demographics
timeFrame: January 1, 2014 to January 1, 2019
measure: Prehospital vitals
timeFrame: January 1, 2014 to January 1, 2019
measure: Emergency department vitals
timeFrame: January 1, 2014 to January 1, 2019
measure: Peri-intubation vitals
timeFrame: January 1, 2014 to January 1, 2019
measure: AIS
timeFrame: January 1, 2014 to January 1, 2019
measure: Death Rate
timeFrame: January 1, 2014 to January 1, 2019
measure: ISS
timeFrame: January 1, 2014 to January 1, 2019
measure: Hospital Length of Stay
timeFrame: January 1, 2014 to January 1, 2019
measure: ICU Length of Stay
timeFrame: January 1, 2014 to January 1, 2019
measure: Ventilation days
timeFrame: January 1, 2014 to January 1, 2019
measure: Return to Hospital in <30d
timeFrame: January 1, 2014 to January 1, 2019
measure: Discharge Disposition
timeFrame: January 1, 2014 to January 1, 2019
measure: Demographics-Sex
timeFrame: January 1, 2014 to January 1, 2019
measure: Demographics-Race
timeFrame: January 1, 2014 to January 1, 2019
measure: Demographics-Trauma Type
timeFrame: January 1, 2014 to January 1, 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Michael S Truitt, MD
role: PRINCIPAL_INVESTIGATOR
References: