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NCT05243420
Commonly Used Drug Regimens for Rapid Sequence Intubation (RSI) of Trauma Patients in the Emergency Department
trial in Trauma Patients. Withdrawn.
1 January 2021
Quick facts
| Lead sponsor | Methodist Health System |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 20 December 2019 |
| Primary completion | 1 January 2021 |
| Estimated completion | 1 January 2022 |
Conditions studied
- Trauma Patients — all drugs for Trauma Patients →
Sponsor
Methodist Health System — full company profile →
Who can join
Adults 18 to 89, any sex, with Trauma Patients. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05243420 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Methodist Health System
- Last refreshed: 24 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05243420.
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