Observational Study of Rapid Sequence Intubation (RSI) Drug Delivery Using Intraosseous (IO) and Intravenous (IV) Access.
This study will evaluate using intraosseous vascular access and intravenous vascular access to give patients the necessary medications to perform rapid sequence intubation, for patients with airway difficulties. The investigators think the device operator will find the intraosseous and intravenous routes equal for drug delivery.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||An Observational Study of Intubating Conditions Comparing Intraosseous Vascular Access With Peripheral Intravenous Access for Drug Delivery in Rapid Sequence Intubation|
- Time from first drug delivery to operator-perceived sufficient relaxation to perform endotracheal tube placement [ Time Frame: during rapid sequence intubation procedure, average expected time frame 30 minutes ] [ Designated as safety issue: No ]
- Intubation difficulty using the intubation difficulty scale [ Time Frame: during rapid sequence intubation procedure, average expected time frame 30 minutes ] [ Designated as safety issue: No ]
- Operator satisfaction with intubating conditions using visual analog scale [ Time Frame: during rapid sequence intubation procedure, average expected time frame 30 minutes ] [ Designated as safety issue: No ]
- Failure rate of endotracheal intubation and requirement for alternative airway management methods [ Time Frame: during rapid sequence intubation procedure, average time frame 30 minutes ] [ Designated as safety issue: No ]
- Incidence of short-term catheter related complications for each technique [ Time Frame: during emergency department stay, average time frame 24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Intravenous (IV) drug delivery
patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery.
Intraosseous (IO) drug delivery
Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery.
This observational study will evaluate the intubating conditions of patients receiving rapid sequence intubation when receiving paralytic drug delivery via intravenous or intraosseous vascular access from the perspective of the medical professional performing rapid sequence intubation. The investigators believe that medical professionals will find equal intubating conditions for intravenous and intraosseous drug delivery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486407
|United States, Texas|
|Christus Spohn Hospital Corpus Christi|
|Corpus Christi, Texas, United States, 78405|
|Texas Tech University Health Science Center El Paso|
|El Paso, Texas, United States, 79905|
|Principal Investigator:||Stephen W Borron, MD||Texas Tech University Health Science Center|