Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05243420 |
| Other study ID # |
069.GME.2019.D |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 20, 2019 |
| Est. completion date |
January 1, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Methodist Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
