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

NCT05243420 | Withdrawn

• 1 other identifier: 069.GME.2019.D
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Patients

Outcome Measures

Primary Outcomes (16)

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult trauma patients with intubation attempt in emergency department

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Methodist Health System: lead
• University of Texas at Austin: collaborator

Study Officials

• Michael S Truitt, MD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: February 17, 2022
• Study Start: December 20, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: March 24, 2026

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)