Clinical trial NCT01486407: Observational Study of Rapid Sequence Intubation (RSI) Drug Delivery Using Intraosseous (IO) and Intravenous (IV) Access.
Official title: An Observational Study of Intubating Conditions Comparing Intraosseous Vascular Access With Peripheral Intravenous Access for Drug Delivery in Rapid Sequence Intubation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Airway Control
Keywords: Airway management
Lead sponsor: Vidacare Corporation
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the emergency department with airway difficulties requiring rapid sequence intubation.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Requires rapid sequence intubation
* Succinylcholine is chosen paralytic agent
* IV or IO access has been established for rapid sequence intubation
* For IV access patients, their rapid sequence intubation case is the next occurring IV rapid sequence intubation case following an enrolled IO RSI case.

Exclusion Criteria:

* Vascular access other than IV or IO has been established

Primary outcomes:
measure: Time from first drug delivery to operator-perceived sufficient relaxation to perform endotracheal tube placement
timeFrame: during rapid sequence intubation procedure, average expected time frame 30 minutes
measure: Intubation difficulty using the intubation difficulty scale
timeFrame: during rapid sequence intubation procedure, average expected time frame 30 minutes
measure: Operator satisfaction with intubating conditions using visual analog scale
timeFrame: during rapid sequence intubation procedure, average expected time frame 30 minutes
measure: Failure rate of endotracheal intubation and requirement for alternative airway management methods
timeFrame: during rapid sequence intubation procedure, average time frame 30 minutes
Secondary outcomes:
measure: Incidence of short-term catheter related complications for each technique
timeFrame: during emergency department stay, average time frame 24 hours
Other outcomes:
Locations:
city: Corpus Christi
country: United States
facility: Christus Spohn Hospital Corpus Christi
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Science Center El Paso
state: Texas
Study officials:
affiliation: Texas Tech University Health Science Center
name: Stephen W Borron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reades R, Studnek JR, Vandeventer S, Garrett J. Intraosseous versus intravenous vascular access during out-of-hospital cardiac arrest: a randomized controlled trial. Ann Emerg Med. 2011 Dec;58(6):509-16. doi: 10.1016/j.annemergmed.2011.07.020.
citation: Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
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citation: Von Hoff DD, Kuhn JG, Burris HA 3rd, Miller LJ. Does intraosseous equal intravenous? A pharmacokinetic study. Am J Emerg Med. 2008 Jan;26(1):31-8. doi: 10.1016/j.ajem.2007.03.024.
citation: Orlowski JP, Porembka DT, Gallagher JM, Lockrem JD, VanLente F. Comparison study of intraosseous, central intravenous, and peripheral intravenous infusions of emergency drugs. Am J Dis Child. 1990 Jan;144(1):112-7. doi: 10.1001/archpedi.1990.02150250124049.
citation: Laurin EG, Sakles JC, Panacek EA, Rantapaa AA, Redd J. A comparison of succinylcholine and rocuronium for rapid-sequence intubation of emergency department patients. Acad Emerg Med. 2000 Dec;7(12):1362-9. doi: 10.1111/j.1553-2712.2000.tb00493.x.
citation: Perry JJ, Lee JS, Sillberg VA, Wells GA. Rocuronium versus succinylcholine for rapid sequence induction intubation. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD002788. doi: 10.1002/14651858.CD002788.pub2.