跳至主要内容
临床试验/NCT05243420
NCT05243420撤回不适用

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

Methodist Health System1 个研究点 分布在 1 个国家开始时间: 2019年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Hospital Length of Stay

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Hospital Length of Stay

时间窗: January 1, 2014 to January 1, 2019

The number of days subject was admitted.

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

时间窗: 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

时间窗: January 1, 2014 to January 1, 2019

Vitals recorded in the emergency department

Demographics

时间窗: January 1, 2014 to January 1, 2019

Age (in years)

Prehospital vitals

时间窗: January 1, 2014 to January 1, 2019

Vital signs collected prior to hospitalization

Peri-intubation vitals

时间窗: January 1, 2014 to January 1, 2019

Vitals recorded prior to intubation

AIS

时间窗: January 1, 2014 to January 1, 2019

(Abbreviated Injury Score)

ISS

时间窗: January 1, 2014 to January 1, 2019

(Injury Severity Score)

Ventilation days

时间窗: January 1, 2014 to January 1, 2019

The number of days the subject ventilated.

Return to Hospital in <30d

时间窗: January 1, 2014 to January 1, 2019

Demographics-Sex

时间窗: January 1, 2014 to January 1, 2019

Male or female

Death Rate

时间窗: January 1, 2014 to January 1, 2019

rate of death

ICU Length of Stay

时间窗: January 1, 2014 to January 1, 2019

The number of days the subject was admitted into the ICU.

Discharge Disposition

时间窗: January 1, 2014 to January 1, 2019

discharge status

Demographics-Race

时间窗: January 1, 2014 to January 1, 2019

Race of subject

Demographics-Trauma Type

时间窗: January 1, 2014 to January 1, 2019

Type of trauma

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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